# K043547: Compress Segmental Femoral Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 5, 2005 after 225 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945028 (1996). 6 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031804: Compress Distal Femoral Replacement, Biomet, Inc. (2003) Summary page 2.
- K041352: Compress Distal Femoral Replacement System, Biomet, Inc. (2004) Summary page 2.
- K002757: Oncology Salvage System, Biomet, Inc. (2000) Summary page 2.
- K952970: Howmedica Femoral & Proximal Tibial Modular Replacement Sytesm, Howmedica Corp. (1996) Summary page 2.
- K972401: Howmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments, Howmedica Corp. (1998)

## Most influential descendants
- K062998: Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) (2007), 10 descendants of its own
- K112905: Compress (R) Segmental Humeral Replacement System (2012), 5 descendants of its own
- K173411: Comprehensive Segmental Revision System (SRS) (2018), 2 descendants of its own
- K080330: Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female Taper (2008), 2 descendants of its own
- K223631: Comprehensive Segmental Revision System (SRS) (2023), 1 descendant of its own

## Recalls of this device
- May 19, 2009 · Not classified · Z-1528-2009: The retaining ring may fall out of the instrument during surgery.
- May 19, 2009 · Not classified · Z-1530-2009: The retaining ring may fall out of the instrument during surgery.
- May 19, 2009 · Not classified · Z-1527-2009: The retaining ring may fall out of the instrument during surgery.
- May 19, 2009 · Not classified · Z-1529-2009: The retaining ring may fall out of the instrument during surgery.
- May 19, 2009 · Not classified · Z-1531-2009: The retaining ring may fall out of the instrument during surgery.
- May 19, 2009 · Not classified · Z-1526-2009: The retaining ring may fall out of the instrument during surgery.

## Indications for use
Indications: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty 4. Trauma The Compress Segmental Femoral Replacement System components are intended for uncemented use only.

Source page: https://510kreport.com/device/K043547
Methodology: https://510kreport.com/methodology