510(k) K190439
K190439 is an FDA 510(k) premarket notification submitted by Engage Uni, LLC for the device "Engage Partial Knee System". The FDA issued a decision of Substantially Equivalent on November 21, 2019. The device falls under product code NJD (Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer), a Class II device regulated under 21 CFR 888.3535.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2019
- Date Received
- February 25, 2019
- 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.