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The Tracker / September 2026 / K261869

510(k) cleared

Integrity Retractable Implant Inserter (6000127)

Anika Therapeutics, Inc. · Sep 17, 2026 · K261869

FDA cleared the Integrity Retractable Implant Inserter (6000127) from Anika Therapeutics, Inc. on Sep 17, 2026 under K261869, a traditional 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 4, 2026. The decision came 105 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Anika Therapeutics, Inc. has one other decision in the tracker over the last 12 months: K261311 (HYALOMATRIX).

Questions & Answers

What did FDA clear under K261869?

K261869 is the FDA 510(k) for Integrity Retractable Implant Inserter (6000127), submitted by Anika Therapeutics, Inc.. FDA's decision date was Sep 17, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Integrity Retractable Implant Inserter (6000127)?

Anika Therapeutics, Inc., based in Beford, MA, is the applicant of record for K261869.

How long did the K261869 review take?

FDA received the submission on Jun 4, 2026 and issued its decision on Sep 17, 2026, 105 days later.

← All decisions in September 2026

Sources