510(k) · Cleared
Recalled · 2008Omnifit HFX Hip Stem Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Aug 8, 2003 as substantially equivalent to K954598 (Osteonics Corp., 1996) after a 64-day review. Its family tree reaches back 1 generation to 1996. 19 later devices descend from it. It has been recalled once.
- Decided
- Aug 8, 2003
- Review
- 64 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954598 (1996). 19 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954598 Osteonics Offset Hip StemsOsteonics Corp. · 1996
- This deviceK031744 Omnifit HFX Hip Stem SeriesHowmedica Osteonics Corp. · 2003
- Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- Descendant · cites it directly · 7 of its ownK211703 Insignia Hip StemStryker Orthopaedics · 2021
- Descendant · 2 generations on · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
- Descendant · 2 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
- K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 2 generations on8descendants
- K211703Insignia Hip StemStryker Orthopaedics · 2021 · cites it directly7descendants
- K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 2 generations on7descendants
- K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954598 | Osteonics Offset Hip Stems | Osteonics Corp. | 1996 | — |
| 0 (this device) | K031744 | Omnifit HFX Hip Stem Series | Howmedica Osteonics Corp. | 2003 | — |
| +1 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +2 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
| +1 | K211703 | Insignia Hip Stem | Stryker Orthopaedics | 2021 | — |
| +2 | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II… | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019 | — |
| +2 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954598 | Osteonics Offset Hip StemsSummary page 2…al Comparison The subject and predicate hip stems are both hip fracture stems intended for cementcd use. The subject devices and the predicatc 6076 series hip stems (K954598)are forged from ASTM E'-799 cobalt chromium alloy. Intended Use The subject devices are intended for single use only, and… | 1996 |
| * | — | Osteonics ODC/ODC Plus Hip Stems Named without a submission number | |
| * | — | Omnifit X (Eon) Hip Stems Named without a submission number |
What descends from it? (19)
See all 192 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2008 | Not classified | Z-0896-2009 | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K153345 (Stryker Orthopaedics, 2016) has gone furthest, with 17 descendants of its own.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (198 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031744 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031744: Omnifit HFX Hip Stem Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031744
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026