# K120038: A200 Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies, LLC
- Decided: Feb 14, 2013 after 406 days
- Product code: OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K810258 (1981). 53 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060515: Depuy PFC Sigma Knee Prosthesis, DePuy Orthopaedics, Inc. (2006) Summary page 2.
- K103223: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Encore Medical L.P. (2010) Summary page 2.
- K100048: E1 Antioxidant Infused Technology, Biomet Manufacturing Corp (2010) Summary page 2.
- K923277: Foundation Knee System, Encore Orthopedics, Inc. (1993) Summary page 3.
- K892800: MG II Porous Total Knee System, Zimmer, Inc. (1989) Summary page 2.
- K932837: Consensus Knee System - Primary Knee, U.S. Medical Products, Inc. (1994) Summary page 2.
- K935080: Insall-Burstein II, Hospital For Special Surgery (1995) Summary page 2.

## Most influential descendants
- K190122: Renovis A200 PS Knee System as part of the Renovis A200 Knee System (2019), 1 descendant of its own
- K243295: Initia Knee System (2025), 0 descendants of its own

## Indications for use
The A200 Knee System is intended for use in total knee arthroplasty for the following indications: 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. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is intended for cemented use only.

Source page: https://510kreport.com/device/K120038
Methodology: https://510kreport.com/methodology