Initially discovered in 1965 by Marshal Urist, bone morphogenetic proteins (BMPs) are the only known proteins capable of inducing new bone formation. For over 20 years, Stryker has been specifically dedicated to the research and development of BMP-7, also known as OP-1 (Osteogenic Protein-1).
HUMANITARIAN DEVICE. OP-1 Putty is authorized by Federal law for use 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. The clinical effectiveness of this device for this use has not been demonstrated.
What are BMPs?
BMP stands for bone morphogenetic protein. BMPs are members of the transforming growth factor beta (TGF-ß) superfamily of extracellular proteins. These factors act by binding to the cell’s exterior and transferring a signal to the nucleus via intracellular proteins called SMADs. This mechanism is essential in the formation and repair of a variety of tissue types including bone.
What is a Humanitarian Device Exemption?
A Humanitarian Device Exemption or HDE is an application to the Food and Drug Administration (FDA) that is a type of a premarket approval (PMA) application, authorizing commercial marketing of a Humanitarian Use Device (HUD). The difference is that the HUD is exempt from the effectiveness requirements of a PMA.
An HUD is a device "intended to benefit patients in the treatment and diagnosis of diseases or conditions that affects or is manifested in fewer than 4,000 individuals in the United States per year."
An HUD also must be approved for use by a hospital's Institutional Review Board (IRB) before it can be used in patients for the designated indication(s).The IRB does not need to review and approve individual uses of an HUD, although it may choose to do so.
What is OP-1?
OP-1 stands for Osteogenic Protein 1, which is also known as BMP-7. OP-1 is an osteoinductive growth factor specific to bone growth and formation. It actively recruits stem cells from the surrounding tissue and initiates the bone formation cascade.
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 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.
Why don’t I see OP-1 Putty on the immediate post-op x-ray?
OP-1 Putty is radiotranslucent. It will not be apparent on immediate post op x-rays, which facilitates the distinction between the implant and new bone formation.
I am concerned about the overgrowth of bone. How do I know that OP-1 Putty will be contained in the posterolateral spine and that there will not be bone formation outside the fusion site?
Good surgical practice, including containment of the device in the posterolateral gutters and proper soft tissue closure is essential to the safety and probable benefit of this device. Additionally, toxicology studies with systematic dosing of excessive doses of OP-1 have failed to show disseminated ectopic bone growth. The dosage of OP-1 has been carefully selected and refined in preclinical studies to provide an appropriate dose while minimizing the occurrence of excessive bone growth at the site of implantation.
How do I know OP-1 Putty is safe?
OP-1 Putty is approved by the FDA under HDE regulations. The FDA has reviewed the preclinical and clinical data and has determined the probable benefits of using the product outweigh the associated risks. OP-1 Putty has demonstrated a consistent safety profile in clinical use since its launch in 2004.
Other companies say they have BMPs in their product. What's new about OP-1?
OP-1 is an inductive growth factor which actively recruits mesenchymal stem cells from surrounding tissue and initiates the bone formation cascade. It is a bone-specific growth factor, and is not a cocktail of growth factors or BMPs that include multiple components, some of which may be inhibitory to bone growth. While a unit of OP-1 Putty contains 3.3 mg of BMP-7, these other products contain negligible levels of BMPs, with questionable reliability, and possible efficacy, in providing consistent osteoinduction.
Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademark(s) or service mark(s): OP-1. All other trademarks are trademarks of their respective owners or holders.