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New Humanitarian Device Approval

OP-1 Putty - H020008

FDA approved this device under the Humanitarian Device Exemption (HDE) program http://www.fda.gov/cdrh/ode/hdeinfo.html. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: OP-1 Putty
Manufacturer: Stryker Biotech
Address: 35 South Street, Hopkinton, Massachusetts 01748
Approval Date: April 7, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf2/H020008a.pdf

What is it? OP-1 Putty is used to make a new posterolateral spinal fusion in patients who have had a failed posterolateral spinal fusion. OP-1 Putty is made from a manufactured (genetically engineered) human protein powder and cow (bovine) collagen that is mixed with a sterile salt water (saline) solution and a thickening agent to form a putty-like material. During surgery, the putty is placed on each side of the spinal levels that need to be fused.

How does it work? The OP-1 Putty may help to form new bone by imitating the body’s own method of bone healing and growth. The OP-1 Putty also gives a physical platform to support new bone that forms.

When is it used? OP-1 Putty can be used in patients who:

• have failed a previous spinal fusion surgery, and
• are not able to provide their own bone or bone marrow for grafting because of a condition such as osteoporosis, diabetes, or smoking.

What will it accomplish? OP-1 Putty may help form a spinal fusion in patients who:

• have failed a previous spinal fusion surgery, and
• are not able to provide their own bone or bone marrow for grafting because of a condition such as osteoporosis, diabetes, or smoking.

When should it not be used? This device should not be used in a patient who:

• is allergic to OP-1, collagen or cow (bovine) products,
• has had a tumor removed at or near the proposed surgery site,
• has a previous history of cancer,
• is under 18 years of age or still growing, or
• is pregnant.

Additional information
Summary of Safety and Probable Benefit and Labeling: http://www.fda.gov/cdrh/ode/H020008sum.html

Other:
National Institutes of Health (NIH) information on spinal fusion:
http://www.nlm.nih.gov/medlineplus/ency/article/002968.htm
NIH information on back pain:
http://www.nlm.nih.gov/medlineplus/backpain.html

Updated April 27, 2004

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