510(k) · Cleared
ClearedOsteonics Offset Hip Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Apr 4, 1996 after a 184-day review. The FDA summary names its predicate without a number. 20 later devices descend from it.
- Decided
- Apr 4, 1996
- Review
- 184 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 1 citing it directly.
- This deviceK954598 Osteonics Offset Hip StemsOsteonics Corp. · 1996
- Descendant · cites it directly · 19 of its ownK031744 Omnifit HFX Hip Stem SeriesHowmedica Osteonics Corp. · 2003 · Recalled
- Descendant · 2 generations on · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · 3 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- Descendant · 2 generations on · 7 of its ownK211703 Insignia Hip StemStryker Orthopaedics · 2021
- Descendant · 3 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
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K031744Omnifit HFX Hip Stem SeriesHowmedica Osteonics Corp. · 2003 · cites it directly19descendants
- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · 2 generations on17descendants
- K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 3 generations on8descendants
- K211703Insignia Hip StemStryker Orthopaedics · 2021 · 2 generations on7descendants
- K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954598 | Osteonics Offset Hip Stems | Osteonics Corp. | 1996 | — |
| +1 | K031744 | Omnifit HFX Hip Stem Series | Howmedica Osteonics Corp. | 2003 | 1 |
| +2 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +3 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
| +2 | K211703 | Insignia Hip Stem | Stryker Orthopaedics | 2021 | — |
| +3 | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II… | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Osteonics® Omnifit® Plus Cemented Hip Stems Named without a submission number | |
| * | — | Osteonics® ODC Hip Stems Named without a submission number | |
| * | — | Osteonics® Restoration Cemented Hip Stems Named without a submission number |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031744 | Omnifit HFX Hip Stem Series | 2003 | 19 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031744 (Howmedica Osteonics Corp., 2003) has gone furthest, with 19 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 Osteonics® Offset Hip Stems are intended for single use in patients requiring either a Total Hip Replacement or a Hemi- or Bipolar Hip Replacement. The Osteonics® Offset Hip Stems are intended to be implanted in cemented or cementless applications. The specific intended uses of the Osteonics® Offset Hip Stems include the following: % head/neck mg or non-unions. Aseptic necrosis of the femoral head. Osteo-, rheumatoid, and post-traumatic arthritis of…
Read the full statement (167 words)
The Osteonics® Offset Hip Stems are intended for single use in patients requiring either a Total Hip Replacement or a Hemi- or Bipolar Hip Replacement. The Osteonics® Offset Hip Stems are intended to be implanted in cemented or cementless applications.
The specific intended uses of the Osteonics® Offset Hip Stems include the following:
% head/neck mg or non-unions.
Aseptic necrosis of the femoral head.
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other considerations for use as a Bipolar or Hemi-Hip Replacement.
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.
Painful, i g joint disease of the hip 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K954598 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954598: Osteonics Offset Hip Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954598
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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