# K031804: Compress Distal Femoral Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 18, 2003 after 190 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: 1 generation back to K945028 (1996). 2 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945028: Finn Knee System, Biomet, Inc. (1996) Summary page 1.
- K972401: Howmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments, Howmedica Corp. (1998) Summary page 1.

## Most influential descendants
- K041352: Compress Distal Femoral Replacement System (2004), 12 descendants of its own
- 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

## Indications for use
The ComPreSsTM Distal Femoral Replacement System is indicated for tumors of the distal femur and revisions of oncologic distal femoral replacements. The ComPreSsTM Distal Femoral Replacement components are intended for uncemented use.

Source page: https://510kreport.com/device/K031804
Methodology: https://510kreport.com/methodology