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The Tracker / September 2026 / K261275

510(k) cleared

Unity Total Knee System, Unity Knee Cementless CR Femur

Corin, Ltd. · Sep 17, 2026 · K261275

FDA cleared the Unity Total Knee System, Unity Knee Cementless CR Femur from Corin, Ltd. on Sep 17, 2026 under K261275, a traditional 510(k). The device falls under product code MBH, Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, regulated at 21 CFR 888.3565 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 17, 2026. The decision came 153 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Corin, Ltd. has one other decision in the tracker over the last 12 months: K261576 (Icona Hip Stem).

Questions & Answers

What did FDA clear under K261275?

K261275 is the FDA 510(k) for Unity Total Knee System, Unity Knee Cementless CR Femur, submitted by Corin, Ltd.. FDA's decision date was Sep 17, 2026, under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer).

Who makes the Unity Total Knee System, Unity Knee Cementless CR Femur?

Corin, Ltd., based in Cirencester, is the applicant of record for K261275.

How long did the K261275 review take?

FDA received the submission on Apr 17, 2026 and issued its decision on Sep 17, 2026, 153 days later.

← All decisions in September 2026

Sources