# K041466: Titanium Femoral Knee Components (Maxim and Agc)

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing Corp
- Decided: Jul 1, 2004 after 29 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 K981996 (1999). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981996: Titanium Femoral Component, Biomet, Inc. (1999) Summary page 1.

## Most influential descendants
- K063515: Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar Knee (2007), 2 descendants of its own
- K203341: ACS LD Uni FB Knee System (2021), 1 descendant of its own
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own

## Indications for use
1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved, 2) Failure of previous joint replacement procedure, 3) Correction of varus, valgus, or posttraumatic deformity. 4) Correction or revision of unsuccessful osteotomy or Arthrodesis * Device designed for use in patients with metal sensitivity. * Standard surgical and rehabilitative procedures are indicated with this device. * The device is a single use device intended for use with bone cement.

Source page: https://510kreport.com/device/K041466
Methodology: https://510kreport.com/methodology