Stryker OP-1 Putty for Spinal Fusion

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 an osteoinductive and osteoconductive bone graft material. OP-1 Putty consists of the recombinant human Osteogenic Protein (rhOP-1), Type I Bovine Bone Collagen Matrix (collagen matrix) and the Putty Additive carboxymethylcellulose sodium (CMC). OP-1 Putty is intended to be reconstituted with sterile saline (0.9%) solution.

OP-1 Putty is provided as 2 units. Each unit is comprised of:
• A 20 mL vial of OP-1 Implant containing one gram of a sterile dry powder consisting of bovine collagen and 3.3 mg of OP-1
• A 10 mL vial of Putty Additive containing 230 mg of sterile carboxymethylcellulose (CMC)

One vial of OP-1 Implant and one vial of Putty Additive must be combined with sterile saline to produce one unit of OP-1 Putty. One unit of OP-1 Putty will be used for each side of the spine.

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.