# K031217: GMRS Press Fit Stems with Purefix HA

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics
- Decided: May 23, 2003 after 36 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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 K022403 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022403: GMRS Press Fit Stems with Purefix HA, Howmedica Osteonics Corp. (2002) Summary page 1.

## Most influential descendants
- K241716: Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component (2024), 0 descendants of its own

## Indications for use
The Global Modular Replacement System (referred to from this point on as the GMRS) Press Fit Stems with PureFixB HA Coating are intended to be used with components of the proximal femoral segment of the Howmedica Modular Replacement System in total hip arthroplasty. These devices are intended for use in total hip arthroplasty indicated as a result of extensive proximal femoral bone loss (from trauma, failed previous arthroplasty, or tumor resection). Adequate bone stock must be present to allow the use of the GMRS Press Fit Stems with PureFixB HA Coating. The 11mm diameter GMRS Press Fit Stems with PureFixB HA will bear a weight limitation on the label. The 11mm stems will be limited to use in patients with a maximum weight of 199 lbs.

Source page: https://510kreport.com/device/K031217
Methodology: https://510kreport.com/methodology