# K190122: Renovis A200 PS Knee System as part of the Renovis A200 Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies
- Decided: Jun 20, 2019 after 146 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- 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: 9 generations back to K810258 (1981). 74 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120038: A200 Knee System, Renovis Surgical Technologies, LLC (2013) Summary page 4.
- K113550: Vanguard Complete Knee System, Biomet Manufacturing Corp (2012) Summary page 4.

## Most influential descendants
- 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 for cemented use only.

Source page: https://510kreport.com/device/K190122
Methodology: https://510kreport.com/methodology