510(k) K242307

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

December 16, 2024

Date Received

August 5, 2024

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

Device Class

Class II

Regulation Number

888.3535

Review Panel

OR

Submission Type

Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.