510(k) · Cleared
ClearedSalvage/Onocology Hip and Total Femur System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Mar 4, 1998 as substantially equivalent to K810258 (Biomet, Inc., 1981) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1981. 508 later devices descend from it.
- Decided
- Mar 4, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K810258 (1981). 3 ancestors in all. 508 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- This deviceK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- Descendant · cites it directly · 505 of its ownK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 355 of its ownK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- Descendant · 2 generations on · 289 of its ownK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
Showing 5 of 508 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 508 · See all- K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · cites it directly505descendants
- K042051Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · 2 generations on355descendants
- K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · 3 generations on344descendants
- K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006 · 4 generations on343descendants
- K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005 · 2 generations on289descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| 0 (this device) | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| +1 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| +2 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| +3 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| +4 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| +2 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 14 | 0 |
| 2012 | 26 | 0 |
| 2013 | 34 | 0 |
| 2014 | 29 | 0 |
| 2015 | 25 | 0 |
| 2016 | 26 | 0 |
| 2017 | 22 | 0 |
| 2018 | 26 | 0 |
| 2019 | 37 | 0 |
| 2020 | 34 | 0 |
| 2021 | 32 | 0 |
| 2022 | 34 | 0 |
| 2023 | 32 | 0 |
| 2024 | 34 | 0 |
| 2025 | 39 | 0 |
| 2026 | 34 | 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 |
|---|---|---|---|
| * | K810258 | Proximal Fermoral Hip ReplacementSummary page 1…e porous surface Tissue growth failure Nerve damage Disassociation of the components Substantially Equivalent Devices: Biomet's Proximal Femoral Hip Replacement 510(k) K810258cleared 3/5/81; Biomet's Mallory/Head Modular Calcar 510(k) K945115cleared 5/2/95; Wright Medical Technology’s S.0.S. Proximal Fem… | 1981 |
| * | K945115 | Mallory-Head Modular Calcar Repacement ComponentsSummary page 1…of the components Substantially Equivalent Devices: Biomet's Proximal Femoral Hip Replacement 510(k) K810258cleared 3/5/81; Biomet's Mallory/Head Modular Calcar 510(k) K945115cleared 5/2/95; Wright Medical Technology’s S.0.S. Proximal Femur 510(k) K933281 cleared 6/7/94 & REALTH B <0 4y,… | 1995 |
| * | K933281 | S.O.S. Proximal FemurSummary page 1…Hip Replacement 510(k) K810258cleared 3/5/81; Biomet's Mallory/Head Modular Calcar 510(k) K945115cleared 5/2/95; Wright Medical Technology’s S.0.S. Proximal Femur 510(k) K933281 cleared 6/7/94 & REALTH B <0 4y, 5 SERVICEg, o Y, a DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Servi… | 1994 |
What descends from it? (508)
See all 5082 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K032396 (Biomet, Inc., 2003) has gone furthest, with 505 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 Salvage/Oncology Hip and Total Femur System is designed to replace the either the enctire femur or a large portion of the proximal femur in cases of severe bone loss most commonly due to oncological diagnoses or limb salvage following multiple revisions.
The device requires the use of a modular head, acetabular component and when used as a total femur replacement a Finn Knee tibial component.
All components of this system are indicated for use with bone cement.
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/K974558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974558: Salvage/Onocology Hip and Total Femur System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974558
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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