# K022403: GMRS Press Fit Stems with Purefix HA

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 17, 2002 after 86 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) MRS Cemented Stems: named in the summary without a submission number
- (no number) Distal Stem Segments of the Restoration Modular Femoral Stem: named in the summary without a submission number

## Most influential descendants
- K031217: GMRS Press Fit Stems with Purefix HA (2003), 1 descendant of its own
- 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 PureFixa 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 PureFixa HA Coating.

Source page: https://510kreport.com/device/K022403
Methodology: https://510kreport.com/methodology