# K041352: Compress Distal Femoral Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 30, 2004 after 71 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945028 (1996). 4 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 17 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 1.
- K972401: Howmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments, Howmedica Corp. (1998) Summary page 1.
- K945028: Finn Knee System, Biomet, Inc. (1996) Summary page 1.
- K002757: Oncology Salvage System, Biomet, Inc. (2000) Summary page 1.

## Most influential descendants
- K043547: Compress Segmental Femoral Replacement System (2005), 11 descendants of its own
- 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

## Indications for use
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® Distal Femoral Replacement components are intended for uncemented use only.

Source page: https://510kreport.com/device/K041352
Methodology: https://510kreport.com/methodology