# K974558: Salvage/Onocology Hip and Total Femur System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 4, 1998 after 89 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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 K810258 (1981). 3 ancestors in all.
508 later devices descend from it; 2 cite it directly.
0 of 512 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810258: Proximal Fermoral Hip Replacement, Biomet, Inc. (1981) Summary page 1.
- K945115: Mallory-Head Modular Calcar Repacement Components, Biomet, Inc. (1995) Summary page 1.
- K933281: S.O.S. Proximal Femur, Wrightmedicaltechnologyinc (1994) Summary page 1.

## Most influential descendants
- K032396: Ringloc 36MM Line and Modular Femoral Heads (2003), 505 descendants of its own
- K042051: Arcomxl Polyethylene Liners (2005), 355 descendants of its own
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads (2005), 344 descendants of its own
- K061312: 36MM Biolox Delta Ceramic Heads (2006), 343 descendants of its own
- K050327: E-Poly (Vitamin E) Acetabular Liners (2005), 289 descendants of its own

## Indications for use
The Salvage/Oncology Hip and Total Femur System is designed to replace the either the enctire femur or a large portion of the proximal femur in cases of severe bone loss most commonly due to oncological diagnoses or limb salvage following multiple revisions. The device requires the use of a modular head, acetabular component and when used as a total femur replacement a Finn Knee tibial component. All components of this system are indicated for use with bone cement.

Source page: https://510kreport.com/device/K974558
Methodology: https://510kreport.com/methodology