Stryker OP-1 Putty for Spinal Fusion

OP-1 Putty is approved under an HDE for spinal fusion
OP-1 Putty is approved under an HDE for spinal fusion
OP-1 Putty is approved under an HDE for spinal fusionOP-1 Putty is placed in the decorticated lateral gutters, bridging the dorsal surfacesof the transverse processesOP-1 Putty is approved under an HDE for spinal fusionReconstituted OP-1 Putty
OP-1 Putty

The active ingredient in OP-1 Putty is recombinant human bone morphogenetic protein-7 (rhBMP-7), also known as Osteogenic Protein 1 or OP-1, formulated with a purified Type I collagen carrier. The product is provided with an additive that yields an easy-to-handle putty that may be placed between the transverse processes of the spine to promote fusion.

Once implanted in the body, OP-1 stimulates natural bone healing by actively recruiting stem cells from the surrounding tissue and blood supply, initiating the bone formation cascade. Through many years of research, the mechanism of action by which this molecule works inside the body has been explored extensively.

OP-1 Putty is approved by the FDA under a Humanitarian Device Exemption (HDE) and is indicated as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.

OP-1 Putty is a combination of 3.5 mg of recombinant human BMP-7 (rhBMP-7) and 1 g of Type I bovine collagen, which is then mixed with 230 mg of carboxymethylcellulose (CMC) and 2.5 cc of sterile saline to yield a moist putty.

See the package insert for OP-1 Putty for the complete list of indications, warnings, precautions, adverse events, clinical results and other important medical information.

For a list of Frequently Asked Questions regarding OP-1 Putty, click here.



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