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# FDA OKs Expanded Efficacy Claim for Arthritis Injection
- URL: https://www.fdaweb.com/fda-oks-expanded-efficacy-claim-for-arthritis-injection/
- Published: 2017-02-01T12:00:00.000Z
- Updated: 2026-09-14T22:04:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137880

FDA has approved an expanded efficacy claim for Zimmer Biomet Holdings’ single-injection viscosupplement Gel-One Cross-linked Hyaluronate for treating knee pain associated with osteoarthritis. The 26-week efficacy claim is associated with the product’s treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs or simple analgesics, according to the company. Gel-One Cross-linked Hyaluronate requires a single 3 mL injection to complete the treatment course, Zimmer Biomet says.