# K031744: Omnifit HFX Hip Stem Series

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 8, 2003 after 64 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954598 (1996). 1 ancestor in all.
19 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954598: Osteonics Offset Hip Stems, Osteonics Corp. (1996) Summary page 2.
- (no number) Osteonics ODC/ODC Plus Hip Stems: named in the summary without a submission number
- (no number) Omnifit X (Eon) Hip Stems: named in the summary without a submission number

## Most influential descendants
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own
- K211703: Insignia Hip Stem (2021), 7 descendants of its own
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 descendants of its own

## Recalls of this device
- Nov 13, 2008 · Not classified · Z-0896-2009: Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

## Indications for use
The subject devices are intended for single use only, and may be used with or without bone cement. The subject devices may be used with an Howmedica Osteonics Endo Head and Neck Extension for hemi-hip arthroplasty, a UHR Universal Head for bipolar hip replacement, or a Howmedica Osteonics C-Taper cobalt chromium head and Howmedica Osteonics acetabular component for conventional total hip arthroplasty. Indications: For use as a bipolar hip replacement Femoral head/neck fractures or non-union, Aseptic necrosis of the femoral head, Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion, Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum, Salvage of failed total hip arthroplasty Femoral Neck Fractures For use as a total hip replacement Painful, disabling joint disease resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis, Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure, Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. Clinical circumstances that require an altered femoral resection level due to proximal fracture, bone loss, or calcar lysis.

Source page: https://510kreport.com/device/K031744
Methodology: https://510kreport.com/methodology