510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120038Substantially Equivalent

A200 Knee System

Renovis Surgical Technologies, LLC, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120038 is the FDA 510(k) clearance record for A200 KNEE SYSTEM, a class II device, cleared for Renovis Surgical Technologies, LLC on under FDA product code OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive). FDA's definition for product code OIY reads: "Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3...". FDA records list 23 510(k) clearances for Renovis Surgical Technologies, LLC, from to . As of , FDA records show no recalls naming K120038.

Clearance record

Decision date
Received
(406 days to decision)
Product code
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Applicant
Renovis Surgical Technologies, LLC 11234 El Camino Real, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OIY

Trailing 12 months
1 clearance under product code OIY in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OIY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260