After almost eight months of review, the FDA has granted Collagen Matrix, Inc., 510(k) clearance of its Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix putty through its spine business unit.
FDA Clears OssiMend® Bioactive Moldable Bone Graft Matrix
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Bone Mineral, Bioactive Glass and Collagen
The OssiMend Bioactive Moldable Bone Graft Matrix, according to FDA documents, is “…composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous putty implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the healing process.”
“The anorganic bone mineral is a natural, porous bone graft material produced by removal of all organic components from bovine bone…and meets ASTM F1581 standard specifications for composition of anorganic bone for surgical implants.”
“The bioactive glass component is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine deep flexor Achilles tendon.”
“The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.”
Indication
When “…combined with either autogenous bone marrow or autograft with saline, the products is indicated for bony voids or gaps, that are not intrinsic to the stability of the bony structure.” The product “…can also be used with autograft as a bone graft extender.”
The molded putty is “packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine)….The putty resorbs and is replaced with bone during the healing process.”
The company, founded in 1997, delivers a line of collagen and mineral based medical devices and currently manufactures finished medical devices represented by five business units—Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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