# K981996: Titanium Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 10, 1999 after 275 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.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices 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 Knee System: named in the summary without a submission number
- (no number) AGC 2000 Total Knee Prosthesis: named in the summary without a submission number
- (no number) MG I Total Knee: named in the summary without a submission number
- (no number) Kinemax Plus Total Knee System: named in the summary without a submission number
- (no number) Genesis Total Knee System: named in the summary without a submission number

## Most influential descendants
- K080204: Vanguard Knee System Titanium Femoral Components (2008), 6 descendants of its own
- K171054: Biomet Knee Joint Replacement Prostheses (2017), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K041466: Titanium Femoral Knee Components (Maxim and Agc) (2004), 3 descendants of its own
- K063515: Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar Knee (2007), 2 descendants of its own

## Indications for use
When used with the AGC and Maxim Knee Systems, the indications for use of the Titanium Femoral Component include 1)painful and disabled knee joint resulting from osteoarthritis, rheumatiod arthritis, or traumatic arthritis where one or more compartments are involved, 2)failure of a previous joint replacement procedure, 3)correction of varus, valgus or post traumatic deformity, and 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. This device is a single use implant for use with bone cement.

Source page: https://510kreport.com/device/K981996
Methodology: https://510kreport.com/methodology