Download Report

Bacterin Biologics
2015 Product Guide
Contents
Welcome to Bacterin Biologics
3
Product Codes Reference
4
BacteRinse Process
7
OsteoSponge
8
OsteoSponge SC
11
OsteoSelect DBM Putty
13
OsteoWrap | OrbitalWrap HD
15
OsteoSTX
16
3Demin
17
BacFast
18
Precision-Milled & Traditional Allografts
19
hMatrix ADM & hMatrix PR ADM
20
Sports Medicine
21
Need More Info?
22
Circle of Life
23
2
bacterin.com
Bacterin is ISO 13485:2003
certified, registered with
the FDA, accredited by
the AATB, and has state
licensures where required.
All current licenses and
certifications can be
found at bacterin.com
Welcome to Bacterin Biologics
Bacterin upholds the highest levels of safety, efficacy, and quality with every product.
About Bacterin
Bacterin is a biotechnology organization focused on biologic-based applications for orthopedic and
reconstructive surgical procedures. We take pride in our role as stewards of the gift of donation and
the dimensional healing that occurs with both, patients and donor families. We thank you for the
role you play in the Circle of Life and invite you to learn more about the Value Bacterin has to offer.
Advanced Processing Technologies
Bacterin has developed a patented demineralization technology that is engineered to preserve the
native growth factors inherent bone. These growth factors are essential for the tissue regeneration
process in the patients’ body. Bacterin has additional patent-pending methods focused on
demineralization of tissue, designed to extend more desirable handling characteristics for the surgeon
and clinical benefits for the patient. Our BacteRinse Process is also utilized ensuring all allografts are
processed aseptically using progressive methods, and finalized with low-dose gamma irradiation.
Proven Clinical Efficacy
Clinical efficacy is of considerable importance to Bacterin and the continuum of care we
strive to provide on behalf of our donors for the patients. Our products have been featured
in various publications yielding results as high as 97.5% fusion rates. We take pride in
knowing the science in our allografts provides the best possible outcomes for patients.
Safety
Patient safety is of the utmost importance. There have been many scientific advances
in irradiation technologies that have minimized the effects on allograft integrity. 100% of
Bacterin allografts and biologic devices are sterilized via low-dose gamma irradiation in the
final packaging, with a sterility assurance level of 10 -6 (SAL 10 -6). This is commonly referred
to as device level sterility and is accomplished using FDA approved, validated methods.
bacterin.com
3
Bacterin Biologics
Product Codes
Call Point Legend
FA
Foot and Ankle
H
Hip
UE
Upper Extremity
S
Spine
K
Knee
PR
Plastic and Reconstructive
C
Cranio-Maxillofacial
W
Wound
OsteoSponge Filler
OsteoSponge Block
FA
FA
H
S
UE
C
K
H
S
UE
109405
OsteoSponge Filler Fine 0.5cc 1–4 mm Chips
109608
OsteoSponge Block 8 mm
109210
OsteoSponge Filler Fine 1.0cc 1–4 mm Chips
109609
OsteoSponge Block 8 mm — 10 pack
109225
OsteoSponge Filler Fine 2.5cc 1–4 mm Chips
109610
OsteoSponge Block 10 mm
109250
OsteoSponge Filler Fine 5.0cc 1–4 mm Chips
109612
OsteoSponge Block 12 mm
109310
OsteoSponge Filler Fine 10.0cc 1–4 mm Chips
109614
OsteoSponge Block 14 mm
109315
OsteoSponge Filler Fine 15.0cc 1–4 mm Chips
109330
OsteoSponge Filler Fine 30.0cc 1–4 mm Chips
OsteoSponge SC
109410
OsteoSponge Filler 1.0cc 4–10 mm Chips
FA
109425
OsteoSponge Filler 2.5cc 4–10 mm Chips
109550
OsteoSponge Filler 5.0cc 4–10 mm Chips
109816
OsteoSponge SC 6 mm
109510
OsteoSponge Filler 10.0cc 4–10 mm Chips
109818
OsteoSponge SC 8 mm
109515
OsteoSponge Filler 15.0cc 4–10 mm Chips
109830
OsteoSponge SC 10 mm
109530
OsteoSponge Filler 30.0cc 4–10 mm Chips
109832
OsteoSponge SC 12 mm
159550
OsteoSponge Filler 5.0cc — Syringe
159510
OsteoSponge Filler 10.0cc — Syringe
OsteoSponge Disc
159515
OsteoSponge Filler 15.0cc — Syringe
FA
K
C
PR
OsteoSponge Strip
109501
OsteoSponge Disc, 10 mm
FA
109502
OsteoSponge Disc, 12 mm
109503
OsteoSponge Disc, 14 mm
H
S
UE
C
109618
OsteoSponge Strip 12 × 8 × 8 mm
109621
OsteoSponge Strip 50 × 5 × 5 mm
OsteoWrap | OrbitalWrap HD
109622
OsteoSponge Strip 50 × 7 × 5 mm
FA
109631
OsteoSponge Strip 20 × 14 × 5 mm
109632
OsteoSponge Strip 20 × 14 × 7 mm
109701
OsteoWrap 10 × 10 mm
109633
OsteoSponge Strip 26 × 19 × 7 mm
109702
OsteoWrap 15 × 10 mm
109634
OsteoSponge Strip 30 × 10 × 7 mm
109703
OsteoWrap 15 × 15 mm
109635
OsteoSponge Strip 50 × 10 × 7 mm
109711
OsteoWrap 20 × 20 mm
109636
OsteoSponge Strip 50 × 20 × 7 mm
109712
OsteoWrap 30 × 30 mm
109637
OsteoSponge Strip 26 × 19 × 7 mm — 2 pack
109713
OsteoWrap 50 × 25 mm
109638
OsteoSponge Strip 26 × 19 × 7 mm — 4 pack
109714
OsteoWrap 70 × 40 mm
109640
OsteoSponge Strip 40 × 15 × 5 mm
109715
OsteoWrap 60 × 50 mm
109722
OrbitalWrap HD - 20 × 20 × 2 mm
109733
OrbitalWrap HD - 30 × 30 × 2 mm
4
bacterin.com
H
S
UE
C
PR
3Demin Cortical Fibers
FA
K
H
S
OsteoSTX
UE
S
109762
3Demin Cortical Fibers 2.5 cc
109705
OsteoSTX 50 mm – 10 per pack
109765
3Demin Cortical Fibers 5.0 cc
109710
OsteoSTX 100 mm – 10 per pack
109760
3Demin Cortical Fibers 10.0 cc
109720
OsteoSTX 200 mm – 10 per pack
3Demin Boats
Traditional Allografts
FA
FA
K
H
S
UE
H
S
UE
109785
3Demin Boat 50 × 25 mm — 2 pack
101006
Ilium Tricortical Block 6 mm
109781
3Demin Boat 100 × 25 mm — 2 pack
101007
Ilium Tricortical Block 7 mm
101008
Ilium Tricortical Block 8 mm
3Demin Strips
101009
Ilium Tricortical Block 9 mm
FA
101010
Ilium Tricortical Block 10 mm
101011
Ilium Tricortical Block 11 mm
K
H
S
UE
109775
3Demin Strip 50 × 10 mm — 2 pack
101012
Ilium Tricortical Block 12–14 mm
109771
3Demin Strip 100 × 10 mm — 2 pack
101015
Ilium Tricortical Block 15 mm
109772
3Demin Strip 200 × 10 mm — 2 pack
101016
Ilium Tricortical Block 16–21 mm
101022
Ilium Tricortical Block 22–25 mm
101040
Ilium Tricortical Strip 40 mm
101045
Ilium Tricortical Strip 45 mm
Precision-Milled Allografts
S
101050
Ilium Tricortical Strip 50 mm
100511
BacFast HD Facet Dowel, 5 mm
101055
Ilium Tricortical Strip 55 mm
100512
BacFast HD Facet Dowel, 6 mm
101060
Ilium Tricortical Strip 60 mm
1563305
Cervical Spacer, Lordotic, 5 mm
103015
Cancellous Crushed 0.1–4 mm 5cc
1563306
Cervical Spacer, Lordotic, 6 mm
103115
Cancellous Crushed 0.1–4 mm 15cc
1563307
Cervical Spacer, Lordotic, 7 mm
103130
Cancellous Crushed 0.1–4 mm 30cc
1563308
Cervical Spacer, Lordotic, 8 mm
103045
Cancellous Crushed 4–10 mm 5cc
1563309
Cervical Spacer, Lordotic, 9 mm
103415
Cancellous Crushed 4–10 mm 15cc
1563310
Cervical Spacer, Lordotic, 10 mm
103430
Cancellous Crushed 4–10 mm 30cc
104205
Unicortical Block 5 mm
104206
Unicortical Block 6 mm
104207
Unicortical Block 7 mm
104208
Unicortical Block 8 mm
104209
Unicortical Block 9 mm
104210
Unicortical Block 10 mm
106040
Fibula Segment 40–100 mm
106101
Fibula Segment 101–150 mm
105300
Femoral Cortical Strut — 200 mm Split
OsteoSelect DBM Putty
FA
H
S
UE
309005
OsteoSelect DBM Putty 0.5cc
309010
OsteoSelect DBM Putty 1.0cc
309025
OsteoSelect DBM Putty 2.5cc
309050
OsteoSelect DBM Putty 5.0cc
309100
OsteoSelect DBM Putty 10.0cc
359025
OsteoSelect DBM Putty 2.5cc — Syringe
359050
OsteoSelect DBM Putty 5.0cc — Syringe
359100
OsteoSelect DBM Putty 10.0cc — Syringe
bacterin.com
5
hMatrix ADM
Sports Medicine
FA
FA
W
K
208030
hMatrix Dermis 2 × 1 cm, Thin
208000
Achilles Tendon w/Bone Block
208031
hMatrix Dermis 4 × 2 cm, Thin
208002
Anterior Tibialis Tendon
208032
hMatrix Dermis 5 × 4 cm, Thin
208003
Posterior Tibialis Tendon
208033
hMatrix Dermis 7 × 5 cm, Thin
208008
Gracilis Tendon
208034
hMatrix Dermis 10 × 5 cm, Thin
208009
Hemi-Patella Tendon
208052
hMatrix Dermis 2 × 1 cm, Medium
208011
Semitendinosus Tendon
208035
hMatrix Dermis 4 × 2 cm, Medium
208012
Whole Patella Tendon w/Quad
208036
hMatrix Dermis 5 × 4 cm, Medium
208013
Whole Patella Tendon w/o Quad
208037
hMatrix Dermis 7 × 5 cm, Medium
208014
Hemi-Patella Tendon w/Quad
208038
hMatrix Dermis 10 × 5 cm, Medium
208015
Peroneus
208043
hMatrix Dermis 2 × 1 cm, Thick
268012
SportMatrix ADM 12 × 1 cm, Medium
208039
hMatrix Dermis 4 × 2 cm, Thick
208040
hMatrix Dermis 5 × 4 cm, Thick
208041
hMatrix Dermis 7 × 5 cm, Thick
208042
hMatrix Dermis 10 × 5 cm, Thick
208231
hMatrix Dermis 4 × 2 cm, Thin, Meshed
208232
hMatrix Dermis 5 × 4 cm, Thin, Meshed
208233
hMatrix Dermis 7 × 5 cm, Thin, Meshed
208234
hMatrix Dermis 10 × 5 cm, Thin, Meshed
hMatrix PR ADM
PR
218166
hMatrix PR - Dermis 16 × 6 cm, Thin
228168
hMatrix PR - Dermis 16 ×8 cm, Medium
228160
hMatrix PR - Dermis 16 × 10 cm, Medium
228208
hMatrix PR - Dermis 20 × 8 cm, Medium
228320
hMatrix PR - Dermis 20 × 16 cm, Medium
Pericardium and Fascia Lata
FA
W
108004
hMatrix Fascia Lata 30 × 30mm
108005
hMatrix Fascia Lata 50 × 40mm
108006
hMatrix Fascia Lata 70 × 50mm
108007
hMatrix Fascia Lata 100 × 50mm
108021
Pericardium 30 × 30mm
108010
Pericardium 40 × 40mm
108018
Pericardium 50 × 40mm
108019
Pericardium 70 × 50mm
108024
Pericardium 100 × 20mm
108020
Pericardium 100 × 50mm
6
bacterin.com
The BacteRinse Proprietary Process
Aseptic Recovery of Donor Tissue
Tissue recovery takes place in prequalified
settings
Direct tissue sampling at time of recovery
Donor Screening Exceeds FDA and
AATB Standards
Extensive microbiological testing on all
recovered donor tissues
Serological testing using the latest NAT
(Nucleic Acid Testing) techniques
Aseptic Processing to Prevent
Introduction of Microbial Bioburden
Utilization of ISO 5 cleanrooms
Processing staff wears full isolation PPE
v
We process each graft in ISO 5
(Class 100) cleanrooms using the
highest level of manual craftsmanship
Meticulous Cleansing of Tissue
Lysing of cellular components
Removal of bone marrow and blood
elements
to consistently meet our product
specifications for the surgical needs
of medical providers. Bacterin has
engineered its processing methods to
effectively clean and decontaminate
allograft tissue while minimizing
Validated, Rigorous Disinfection of
Tissue
Proven log reduction against a panel of
representative microbes
Effective removal of processing reagents
exposure of the extracellular matrices to
potentially damaging treatment steps.
Validated Sterilization with an SAL of 10-6
This preserves the osteoinductive
Low dose, low temp
potential of our DBM allografts
ASNI/AAMI/ISO VD MAX or Method 2B
and maintains the biomechanical
integrity of our soft tissue grafts.
bacterin.com
7
OsteoSponge Features
JJ
100% human demineralized cancellous bone
JJ
Osteoconductive, interconnected porosity
JJ
Osteoinductive potential
JJ
Elastic, compressible handling characteristics
JJ
Radiolucent to allow for accurate follow-up
JJ
Sterility assurance level (SAL) 10 -6
JJ
5 year shelf life, room-temperature storage
OsteoSponge can be cut to
perfectly fit any cage
OsteoSponge Benefits
OsteoSponge is a novel form of demineralized bone matrix (DBM) made from 100% bone. Derived from trabecular
bone, OsteoSponge provides a natural scaffold for cellular ingrowth and exposes bone-growth-inducing proteins
to the healing environment. The malleable properties of OsteoSponge enable it to fill and conform to irregular bony
defects. Due to its shape memory characteristics, OsteoSponge will expand to completely fill a void after graft
placement. The unique mechanical and biological properties make OsteoSponge an ideal bone graft for use with all
non-weight bearing applications where fusion is desired.
The compressible characteristics of
OsteoSponge
OsteoSponge Strip
OsteoSponge Block
8
bacterin.com
“OsteoSponge absolutely works. I haven’t worked with a product
that is as reliable and easy to work with as OsteoSponge.”
Dr. Kevin Stevenson, MD
The Science
OsteoSponge is processed with a validated method which includes a
patented demineralization step engineered to preserve growth factors
native to cancellous bone. The efficacy and saftey of this processing
method has been clinically proven. When utilized in TLIF procedures in
the lumbar spine, OsteoSponge has demonstrated fusion rates equivalent
to historical controls without any reported complications.1 OsteoSponge
has been successfully utilized in foot and ankle fusion procedures. Both
retrospective2 and prospective3 data indicate that OsteoSponge can produce
Figure 1
fusion rates equivalent to or higher than historic controls. Reported pain
and function outcomes were statistically improved over historical controls.
Growth factors found in bone

TGF-(Beta) 1-5

PDGF AA,AB,BB

BMP 1-12

IGF 1,2

FGF
1 Girasole, G. et al,. (2013) Transforaminal lumbar interbody fusion rates in patients using a novel titanium implant and
demineralized cancellous allograft bone sponge. International Journal of Spine Surgery. 7: e95-e100.
2 Brigido, S.A. et al., (2013) A Retrospective Analysis Evaluating Allogenic Cancellous Bone Sponge for Foot and Ankle Arthrodesis.
The Journal of Foot and Ankle Surgery. 52: 28-31.
Figure 2
3 Protzman, N.M. et al., (2014) Biologic Augementation of Foot and Ankle Arthrodesis With an Allogenic Cancellous Sponge.
Orthopedics. March 37(3): e230-e236.
Figures 1 and 2 (above)
Neovascularization, osteoid formation, and
new bone growth has been consistently
observed in subcutaneous and intramuscular
implants of OsteoSponge. These results
suggest that in addition to providing an
excellent natural scaffold for cellular ingrowth
To see full, published articles regarding the
clinical efficacy of Bacterin biologics,
please visit bacterin.com.
and proliferation, OsteoSponge also contains
growth factors.
bacterin.com
9
OsteoSponge
Competitive Comparison
Few allografts on the market achieve similar
clinical efficacy as OsteoSponge, without
compromising patient safety and ease of use
Osteoinductive
Response in
Animal Model
Contains
Bioavailable
BMPs
Sterile
(SAL) 10 -6
Trabecular
Bone
Structure
Interconnected
Porosity
Osteoconductive
Easily Loaded
With BMA
Room
Temperature
Storage
Cervical Spine
Indication
OsteoSponge (Bacterin)
Infuse
®
(Medtronic)
OsteoCel Plus (NuVasive)
®
Trinity Elite™ (MTF/Orthofix)
®
Chronos (DePuy)
Vitoss
®
(Stryker)
Actifuse
®
(Baxter)
Crushed Cancellous
PRP (Autologous)
Bacterin was the first tissue bank to market an
allograft specifically designed for its compressible
handling characteristics, osteoconductivity, and
osteoinductive potential. If you aren’t using OsteoSponge,
you aren’t using the original ideal bone graft.
10
bacterin.com
Posterior
Spinal Fusion
Indication
OsteoSponge SC Features
JJ
Slightly contoured for ease of placement
JJ
Osteoconductive, interconnected porosity
JJ
Osteoinductive potential
JJ
Elastic, compressible handling characteristics
JJ
Radiolucent to allow for accurate follow-up
JJ
Sterility assurance level (SAL) 10 -6
JJ
5 year shelf life, room-temperature storage
OsteoSponge SC Benefits
OsteoSpnge SC
OsteoSponge SC is sterile, radiolucent, has a 5-year shelf life at room
temperature, and is characterized by malleable handling properties,
making it an excellent alternative to autologous bone or synthetic
materials to effectively, safely, and efficiently repair subchondral
defects in the knee or other articulating joints. Published clinical data
confirm the results of a large animal study demonstrating restoration
of the subchondral bone and a healthy joint environment.
OsteoSponge SC Surgical
Instrumentation Kit
Available Upon Request
Side View Shows the
Tapered Shape of
OsteoSpnge SC
bacterin.com
11
OsteoSponge Block
OsteoSponge Strip
109608
OsteoSponge Block 8mm
109618
OsteoSponge Strip 12 × 8 × 8mm
109609
OsteoSponge Block 8mm – 10 pack
109621
OsteoSponge Strip 50 × 5 × 5mm
109610
OsteoSponge Block 10mm
109622
OsteoSponge Strip 50 × 7 × 5mm
109612
OsteoSponge Block 12mm
109631
OsteoSponge Strip 20 × 14 × 5mm
109614
OsteoSponge Block 14mm
109632
OsteoSponge Strip 20 × 14 × 7mm
109633
OsteoSponge Strip 26 × 19 × 7mm
109634
OsteoSponge Strip 30 × 10 × 7mm
OsteoSponge Filler
109405
OsteoSponge Filler Fine 0.5cc 1–4 mm Chips
109635
OsteoSponge Strip 50 × 10 × 7mm
109210
OsteoSponge Filler Fine 1.0cc 1–4 mm Chips
109636
OsteoSponge Strip 50 × 20 × 7mm
109225
OsteoSponge Filler Fine 2.5cc 1–4 mm Chips
109637
OsteoSponge Strip 26 × 19 × 7mm - 2 pack
109250
OsteoSponge Filler Fine 5.0cc 1–4 mm Chips
109638
OsteoSponge Strip 26 × 19 × 7mm - 4 pack
109310
OsteoSponge Filler Fine 10.0cc 1–4 mm Chips
109640
OsteoSponge Strip 40 × 15 × 5mm
109315
OsteoSponge Filler Fine 15.0cc 1–4 mm Chips
109330
OsteoSponge Filler Fine 30.0cc 1–4 mm Chips
109410
OsteoSponge Filler 1.0cc 4–10 mm Chips
109425
OsteoSponge Filler 2.5cc 4–10 mm Chips
109550
OsteoSponge Filler 5.0cc 4–10 mm Chips
109510
OsteoSponge Filler 10.0cc 4–10 mm Chips
109515
OsteoSponge Filler 15.0cc 4–10 mm Chips
109530
OsteoSponge Filler 30.0cc 4–10 mm Chips
159550
OsteoSponge Filler 5.0cc — Syringe
109816
OsteoSponge SC 6 mm Defect
159510
OsteoSponge Filler 10.0cc — Syringe
109818
OsteoSponge SC 8 mm Defect
159515
OsteoSponge Filler 15.0cc — Syringe
109830
OsteoSponge SC 10 mm Defect
109832
OsteoSponge SC 12 mm Defect
OsteoSponge Disc
109501
OsteoSponge Disc, 10 mm
109502
OsteoSponge Disc, 12 mm
109503
OsteoSponge Disc, 14 mm
OsteoSponge SC
See the unique handling
characteristics of
OsteoSponge, and other
Bacterin biologics at:
bacterin.com/videos
12
bacterin.com
OsteoSelect DBM Putty Features
JJ
Osteoinductive
JJ
Osteoconductive
JJ
Sterility assurance level (SAL) 10 -6
JJ
Exceptional handling characteristics
JJ
Sterile, room-temperature storage
JJ
Will not dissipate upon direct irrigation
JJ
Contains 74% demineralized bone matrix (DBM) by dry weight
OsteoSelect DBM Putty
OsteoSelect DBM Putty Benefits
OsteoSelect DBM Putty is engineered with the surgeon in mind.
With exceptional handling characteristics, OsteoSelect DBM Putty can be
easily molded into any shape and compressed into bone voids. Taking the
design a step further, Bacterin has validated a low-dose, low-temperature
gamma sterilization process to provide maximum osteoinductive potential
while still imparting device-level sterility. Every lot of OsteoSelect DBM Putty
is tested for osteoinductivity after gamma sterilization in an animal model.
Indications
OsteoSelect DBM Putty is indicated for use as a bone void filler and bone
graft substitute for voids or gaps that are not intrinsic to the stability of
the bony structure. OsteoSelect DBM Putty is indicated for treatment of
surgically created osseous defects or osseous defects from traumatic
injury to the bone. OsteoSelect DBM Putty can be used as follows:
Extremities
Posterolateral Spine
Pelvis
OsteoSelect DBM Putty
OsteoSelect DBM Putty
in a syringe
309005
OsteoSelect DBM Putty 0.5 cc
309010
OsteoSelect DBM Putty 1.0 cc
309025
OsteoSelect DBM Putty 2.5 cc
309050
OsteoSelect DBM Putty 5.0 cc
309100
OsteoSelect DBM Putty 10.0 cc
359025
OsteoSelect DBM Putty 2.5 cc – syringe
359050
OsteoSelect DBM Putty 5.0 cc – syringe
359100
OsteoSelect DBM Putty 10.0 cc – syringe
bacterin.com
13
OsteoSelect DBM Putty
Competitive Comparison
OsteoSelect DBM Putty is a highly competitive product
in the demineralized bone matrix space, providing
many benefits to the surgeon and the patient.
Osteoconductive
100% lot testing for
osteoinductive potential
animal model (in vivo)
Sterile R (SAL) 10 -6
Osteoinductive potential
tested after sterilzation
Room Temp Storage
OsteoSelect DBM Putty (Bacterin)
Progenix
DBX
®
®
(Medtronic)
(DePuy Synthes)
Grafton (Medtronic)
N/A
N/A
Accell (Integra)
Dynagraft II (Integra)
The Science
OsteoSelect DBM Putty utilizes a proprietary process engineered to preserve the growth factors
found in cortical bone and provide the highest degree of safety (SAL 10 -6) This validated proprietary
method consistently demonstrates its efficacy in vivo as every lot of OsteoSelect DBM Putty
is proven to induce bone formation in a validated pre-clinical model after terminal sterilization.
OsteoSelect DBM Putty has been shown to be equivalent to autograft when used as a bone graft
substitute in a pre-clinical, un-instrumented posterior spinal fusion model.1 OsteoSelect DBM Putty
has also been shown to be superior to a commercially available synthetic bone void filler.2
1 Kiely, P.D. et al., (2014) Evaluation of a new formulation of demineralized bone matrix putty in a rabbit posterolateral spinal fusion model. The Spine Journal. September 14(9): 2155-2163.
2 Schallenberger et al., (2014) Comparison of the Osteogenic Potential of OsteoSelect Demineralized Bone Matrix Putty to NovaBone Calcium-Phosphosilicate Synthetic Putty in a Cranial Defect
Model. The Journal of Craniofacial Surgery. March 25(2): 657-661.
14
bacterin.com
OsteoWrap & OrbitalWrap HD Features
JJ
JJ
Demineralized cortical bone sheet
Radiolucent to allow for accurate follow-up
assessment of bone formation
JJ
Osteoconductive & osteoinductive potential
JJ
Flexible handling characteristics
JJ
Sterility assurance level (SAL) 10 -6
JJ
5 year shelf life, Room-temperature storage
OsteoWrap
OsteoWrap Benefits
OsteoWrap is 100% human cortical bone demineralized through a proprietary process that makes the
graft flexible while maintaining allograft integrity. In addition to its unique handling characteristics,
OsteoWrap can be easily sized with a scalpel or scissors, and it may be sutured in place. The versatility of the
OsteoWrap allograft makes it an ideal scaffold for use in spine, neuro, cranio-maxillofacial, reconstructive,
and general orthopedic surgical procedures, to provide additional structural support as an overlay graft.
OrbitalWrap HD Benefits
OrbitalWrap HD is a unique and cost-competitive biologic solution that alleviates the need for
permanent implants. This low-profile graft can be easily contoured over a defect in the patient’s
orbital floor. If desired, OrbitalWrap HD can be used in conjunction with traditional implants.
Designed to have similar attributes to OsteoWrap, OrbitalWrap HD is slightly less flexible.
OrbitalWrap HD
OsteoWrap | OrbitalWrap HD
109701
OsteoWrap 10 × 10 mm
109702
OsteoWrap 15 × 10 mm
109703
OsteoWrap 15 × 15 mm
109711
OsteoWrap 20 × 20 mm
109712
OsteoWrap 30 × 30 mm
109713
OsteoWrap 50 × 25 mm
109714
OsteoWrap 70 × 40 mm
109715
OsteoWrap 60 × 50 mm
109722
OrbitalWrap HD - 20 × 20 × 2 mm
109733
OrbitalWrap HD - 30 × 30 × 2 mm
bacterin.com
15
OsteoSTX Features
JJ
Osteoconductive
JJ
Osteoinductive potential
JJ
Sterility assurance level (SAL) 10 -6
JJ
Flexible handling characteristics
JJ
Sterile, room-temperature storage
JJ
Easily cut to size, available in multiple lengths
JJ
Conveniently distributed in packs of 10
OsteoSTX Benefits
OsteoSTX are demineralized cortical sticks processed from donated
human bone. Our proprietary demineralization technology gives
the osteoconductive scaffold flexible handling characteristics and
osteoinductive properties. When combined with BMA, OsteoSTX
provide all of the necessary elements for bone regeneration. OsteoSTX
are designed for posterolateral spine surgery applications including
single- and multi-level fusions, as well as deformity procedures.
OsteoSTX
109705
OsteoSTX 50 mm – 10 per pack
109710
OsteoSTX 100 mm – 10 per pack
109720
OsteoSTX 200 mm – 10 per pack
OsteoSTX can be
easily cut to size
16
bacterin.com
3Demin Features
JJ
Osteoconductive
JJ
Sterile, room-temperature storage
JJ
Osteoinductive potential
JJ
Will not dissipate upon direct irrigation
JJ
Sterility assurance level (SAL) 10 -6
JJ
100% human demineralized cortical bone
JJ
Exceptional handling characteristics
3Demin Benefits
Bacterin’s 3Demin Technology utilizes demineralized cortical bone fibers
that are entangled and shaped into sizes engineered to compliment
specific surgical applications. This unique process creates an
interconnected graft material that contains BMPs and other growth
factors necessary for the promotion of new bone formation. 3Demin
allografts are flexible upon hydration and each allograft has a sterility
3Demin Boat
assurance level of 10 -6 via low-dose gamma sterilization. 3Demin allografts
are also available as loose cortical fibers in three volume options.
3Demin Strip
3Demin Cortical Fibers
3Demin Cortical Fibers
109762
3Demin Cortical Fibers 2.5 cc
109765
3Demin Cortical Fibers 5.0 cc
109760
3Demin Cortical Fibers 10.0 cc
3Demin Boats
109785
3Demin Boat 50 × 25 mm — 2 pack
109781
3Demin Boat 100 × 25 mm — 2 pack
3Demin Strips
109775
3Demin Strip 50 × 10 mm — 2 pack
109771
3Demin Strip 100 × 10 mm — 2 pack
109772
3Demin Strip 200 × 10 mm — 2 pack
bacterin.com
17
Precision-Milled Allografts
BacFast HD
BacFast HD
BacFast HD Surface via a
Scanning Electron Microscope
(SEM) at a magnification of 22x
BacFast HD is a facet stabilization dowel designed with a focus on
osteoconductivity and preventing graft migration, making it an ideal graft to
be used as a complement to common spinal fusion procedures as it preserves
the posterior spine. Utilizing Bacterin’s proprietary demineralization technology,
BacFast HD is hyper-demineralized to expose the growth factors and BMPs
inherent to cortical bone. With the benefits of HD technology and increased
collagen surface area, BacFast HD also provides the graft with osteoinductive
properties without compromising the structural integrity of the graft.
Cervical Interbody Spacers
Precision-Milled Allografts offer the support your patient needs. We have
a cervical footprint that is 12 mm × 14 mm with varying heights and
7 degree lordosis. Cervical spacers feature ridged contact surfaces to
help reduce the incidence of graft migration. The central lumen is ideal
for press-fit placement of OsteoSponge blocks for great fusion results.
Precision-Milled
Cervical Spacer
BacFast HD on Inserter
Instrumentation Surgical Kits
Precision-Milled Allografts
available upon request
18
bacterin.com
100511
BacFast HD Facet Dowel, 5 mm
100512
BacFast HD Facet Dowel, 6 mm
1563305
Cervical Spacer, Lordotic, 5 mm
1563306
Cervical Spacer, Lordotic, 6 mm
1563307
Cervical Spacer, Lordotic, 7 mm
1563308
Cervical Spacer, Lordotic, 8 mm
1563309
Cervical Spacer, Lordotic, 9 mm
1563310
Cervical Spacer, Lordotic, 10 mm
Traditional Allografts
Traditional Allografts
In addition to Bacterin’s proprietary allograft portfolio, select traditional
allografts are available. These matrices are used for multi-disciplinary
applications including: Spine, Neuro, Trauma, Foot and Ankle, Sports
Medicine, Cranio-Maxillofacial, and Plastic/Reconstructive Procedures.
Unicortical Block
Traditional Allografts
Tricortical Block
Femoral Cortical Strut, Split
101006
Ilium Tricortical Block 6 mm
101007
Ilium Tricortical Block 7 mm
101008
Ilium Tricortical Block 8 mm
101009
Ilium Tricortical Block 9 mm
101010
Ilium Tricortical Block 10 mm
101011
Ilium Tricortical Block 11 mm
101012
Ilium Tricortical Block 12–14 mm
101015
Ilium Tricortical Block 15 mm
101016
Ilium Tricortical Block 16–21 mm
101022
Ilium Tricortical Block 22–25 mm
101040
Ilium Tricortical Strip 40 mm
101045
Ilium Tricortical Strip 45 mm
101050
Ilium Tricortical Strip 50 mm
101055
Ilium Tricortical Strip 55 mm
101060
Ilium Tricortical Strip 60 mm
103015
Cancellous Crushed 0.1–4 mm 5cc
103115
Cancellous Crushed 0.1–4 mm 15cc
103130
Cancellous Crushed 0.1–4 mm 30cc
103045
Cancellous Crushed 4–10 mm 5cc
103415
Cancellous Crushed 4–10 mm 15cc
103430
Cancellous Crushed 4–10 mm 30cc
104205
Unicortical Block 5 mm
104206
Unicortical Block 6 mm
104207
Unicortical Block 7 mm
104208
Unicortical Block 8 mm
104209
Unicortical Block 9 mm
104210
Unicortical Block 10 mm
106040
Fibula Segment 40–100 mm
106101
Fibula Segment 101–150 mm
105300
Femoral Cortical Strut — 200 mm Split
bacterin.com
19
hMatrix ADM Features
JJ
Sterility assurance level (SAL) 10 -6
JJ
Superior strength *
JJ
Flexible matrix for precise placement
JJ
Decreased inflammatory response *
JJ
hMatrix ADM and hMatrix PR ADM are distributed as a frozen product
JJ
5 year shelf life (with proper storage conditions)
hMatrix Q Code
Q4134
hMatrix PR ADM
hMatrix ADM
hMatrix ADM and hMatrix PR ADM Benefits
hMatrix Acellular Dermis (ADM) and hMatrix PR ADM are allografts derived from
donated human skin. The dermis is processed using a proprietary method to remove
the cells minimizing the chance of an immunologic response. The natural collagen
and elastin matrix is ideal for neovascularization and cellular proliferation and has the
potential to expedite the healing process. Because it is processed from human donors,
the risk of inflammation is significantly reduced relative to products of animal origin.
Suture Retention Strength
of hMatrix ADM and
hMatrix PR ADM *
Test results demonstrate an average suture retention
strength of 310 Newtons (n = 12) for hMatrix ADM
and hMatrix PR ADM compared to 229 Newtons
(n = 10) for a leading competitive product. Overall,
hMatrix ADM and hMatrix PR ADM were 35%
stronger than the leading competitor (P = 0.002)
with more consistent suture retention strength.
††
*
20
Barber FA, Herbert MA, Coons DA (2006) Tendon Augmentation Grafts: Biomechanical
Failure Loads and Failure Patterns. Arthroscopy: The Journal of Arthroscopic and Related
Surgery. Vol 22, No 5 (May): 534-538.
Data on File at Bacterin.
bacterin.com
350
300
250
200
150
100
50
0
hMatrix ADM &
hMatrix PR ADM
Competitor †
hMatrix ADM
hMatrix PR ADM
208030
hMatrix Dermis 2 × 1 cm, Thin
218166
hMatrix PR - Dermis 16 × 6 cm, Thin
208031
hMatrix Dermis 4 × 2 cm, Thin
228168
hMatrix PR - Dermis 16 ×8 cm, Medium
208032
hMatrix Dermis 5 × 4 cm, Thin
228160
hMatrix PR - Dermis 16 × 10 cm, Medium
208033
hMatrix Dermis 7 × 5 cm, Thin
228208
hMatrix PR - Dermis 20 × 8 cm, Medium
208034
hMatrix Dermis 10 × 5 cm, Thin
228320
hMatrix PR - Dermis 20 × 16 cm, Medium
208052
hMatrix Dermis 2 × 1 cm, Medium
208035
hMatrix Dermis 4 × 2 cm, Medium
Pericardium and Fascia Lata
208036
hMatrix Dermis 5 × 4 cm, Medium
108004
hMatrix Fascia Lata 30 × 30 mm
208037
hMatrix Dermis 7 × 5 cm, Medium
108005
hMatrix Fascia Lata 50 × 40 mm
208038
hMatrix Dermis 10 × 5 cm, Medium
108006
hMatrix Fascia Lata 70 × 50 mm
208043
hMatrix Dermis 2 × 1 cm, Thick
108007
hMatrix Fascia Lata 100 × 50 mm
208039
hMatrix Dermis 4 × 2 cm, Thick
108021
Pericardium 30 × 30 mm
208040
hMatrix Dermis 5 × 4 cm, Thick
108010
Pericardium 40 × 40 mm
208041
hMatrix Dermis 7 × 5 cm, Thick
108018
Pericardium 50 × 40 mm
208042
hMatrix Dermis 10 × 5 cm, Thick
108019
Pericardium 70 × 50 mm
208231
hMatrix Dermis 4 × 2 cm, Thin, Meshed
108024
Pericardium 100 × 20 mm
208232
hMatrix Dermis 5 × 4 cm, Thin, Meshed
108020
Pericardium 100 × 50 mm
208233
hMatrix Dermis 7 × 5 cm, Thin, Meshed
208234
hMatrix Dermis 10 × 5 cm, Thin, Meshed
Sports Medicine
Sports Medicine allografts are an excellent
replacement option for deficient or torn cruciate
ligament reconstructions and revisions. Benefits
Achilles Tendon
of Bacterin’s Sports Medicine allografts include
consistent, superior quality and precise measurements.
As with all of Bacterin’s allografts, safety and
efficacy are an absolute priority. All tendons are
distributed sterile via low-dose gamma irradiation.
Hemi-Patella Tendon
Sports Medicine
208000
Achilles Tendon w/Bone Block
208002
Anterior Tibialis Tendon
208003
Posterior Tibialis Tendon
208008
Gracilis Tendon
208009
Hemi-Patella Tendon
208011
Semitendinosus Tendon
208012
Whole Patella Tendon w/ Quad
208013
Whole Patella Tendon w/o Quad
208014
Hemi-Patella Tendon w/Quad
208015
Peroneus
268012
SportMatrix 12 × 1 cm
bacterin.com
21
GPO Affiliations
As part of our commitment to provide
you with the most cost savings,
we have partnered with Group
Purchasing Organizations nationwide.
Please contact our Customer Service
Department at [email protected] or
1.888.886.9354 for more information.
Bacterin is Just a Click Away
If you are a Bacterin Distributor or Materials Manager and would like access
to our Online Customer Service Portal, please contact our Customer Service
Department for an application. Our portal will provide you with easy access
for submitting online orders, a training calendar, and available downloads
such as published papers, whitepapers, technique guides, instructions for
use, and educational videos. We look forward to adding you as part of our
online community and making access to information available at the click of
a button.
Bacterin Reimbursement Hotline
Bacterin’s Reimbursement Hotline is dedicated to providing answers to all
your reimbursement questions. It also serves as a resource for obtaining
accurate billing information and reimbursement support for Bacterin
products.
hMatrix Q Code
Q4134
1.844.252.4429
MONDAY–FRIDAY. 9AM–4PM CENTRAL.
22
bacterin.com
Distributors
Like what you see and want to
become a distributor for Bacterin?
Or if you have a recommendation for
a Distributor that you enjoy working
with, please contact us at bacterin.
com/contact/distributors.
Returns
For information regarding returns,
please contact our Customer Service
Department at [email protected] or
1.888.886.9354.
Not all products qualify.
Honoring the Gift
The Gift of Donation with
Family Consent
At Bacterin, we are honored to be
stewards of the gift of donation.
Recovery and Transfer
of Tissue
Patients Quality of Life
is Greatly Enhanced
Our respect for representing
the wishes of the donor drives
every decision we make. Bacterin
serves a role throughout the
entire process, from overseeing
donor recovery to manufacturing,
ensuring the highest possible
graft quality and consistency, and
Surgical
Implantation
of Tissue
Bacterin Sterilely Processes
and Packages Tissue
distribution to our customers.
In turn, this attention to detail
in the recovery process, donor
screening, and processing of our
allografts reflects our respect not
Hospital Accepts
Tissue
Tissue is Shipped via a
Validated Carrier
only for the donor, but extends
to the recipient as well.
Bacterin values the role you play in the Circle of Life.
If you would like more information please visit:
http://bacterin.com/DonateLife
Donate Life America
Bacterin is a proud supporter of Donate Life America and the Donate
Life Rose Parade Float. Each year Bacterin, along with our recovery
partners, sponsors hundreds of dedication roses, and in recent years
memorial ‘floragraph’ portraits of organ, eye, and tissue donors
honored and displayed on the Donate Life Rose Parade Float.
bacterin.com
23
600 Cruiser Lane
Belgrade, MT 59714
P: 1.888.886.9354
F: 1.406.388.3380
[email protected]
www.bacterin.com
14008B 04/2015 © 2012 – 2015 Bacterin International, Inc. All Rights Reserved.
BacFast , hMatrix , OrbitalWrap , OsteoLock , OsteoSelect , OsteoSponge , OsteoWrap , and BacteRinse are registered trademarks of Bacterin International, Inc.
®
®
®
®
®
®
3Demin™, SportMatrix™, and OsteoSTX™ are trademarks of Bacterin International, Inc.
Records on file at Bacterin International, Inc.
®
®