# K984054: Agc V2 Revision Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 30, 1999 after 259 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: 1 generation back to K833921 (1984). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833921: Agc Total Knee Prosthesis, Biomet, Inc. (1984) Summary page 1.
- K912245: Agc Revision Knee Prothesis, Biomet, Inc. (1991) Summary page 1.
- K915132: MCK Maximum Congruent Knee) Knee System, Biomet, Inc. (1992) Summary page 1.

## Most influential descendants
- K094013: HLS Kneetec System (2011), 1 descendant of its own
- K111970: Kneetec PFJ&HLS Kneetec Patellar Component (2012), 0 descendants of its own

## Indications for use
Osteoarthritis, rheumatoid arthritis or traumatic arthritis Failure of a previously failed joint replacement procedure Correction of varus, valgus or post-traumatic deformity Correction or revision of unsuccessful'osteotomy or arthrodesis The device is intended for use with bone cement (Usa)

Source page: https://510kreport.com/device/K984054
Methodology: https://510kreport.com/methodology