# K012348: Maxim RPG PS Femoral Component

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Aug 15, 2001 after 22 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Maxim® PS Femoral Component: named in the summary without a submission number

## Indications for use
The Maxim® RPG PS Femoral Component is 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) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is intended for use with bone cement.

Source page: https://510kreport.com/device/K012348
Methodology: https://510kreport.com/methodology