510(k) · Cleared
ClearedProximal Fermoral Hip Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDO Device, Fixation, Proximal Femoral, Implant
Cleared on Mar 5, 1981 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 509 later devices descend from it.
- Decided
- Mar 5, 1981
- Review
- 34 days
- Class
- Class II
- Product code
- JDO
- Recalls
- None
- Predicates
- 0
509 later devices descend from it, 1 citing it directly.
- This deviceK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- Descendant · cites it directly · 508 of its ownK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- Descendant · 2 generations on · 505 of its ownK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 355 of its ownK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- Descendant · 5 generations on · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
Showing 5 of 509 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 509 · See all- K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998 · cites it directly508descendants
- K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · 2 generations on505descendants
- K042051Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · 3 generations on355descendants
- K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · 4 generations on344descendants
- K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006 · 5 generations on343descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| +1 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| +2 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| +3 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| +4 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| +5 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDO? 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 JDO device
- #1 K213126 Smith & Nephew, Inc. Plates and Screws…score 12.0 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (509)
See all 5091 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974558 | Salvage/Onocology Hip and Total Femur System | 1998 | 508 |
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, K974558 (Biomet, Inc., 1998) has gone furthest, with 508 descendants of its own.
How does its category compare?
All JDO devicesJDO Device, Fixation, Proximal Femoral, Implant: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDO
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JDO
Too few JDO 510(k)s in any year since 2007 to give a median.
Recalls per year · JDO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDO
1in 2025
MAUDE reports naming product code JDO, 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 | 0 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 1 | 52 |
| 2014 | 1 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 19 |
| 2016 | 1 | — | 0 | 44 |
| 2017 | 1 | — | 0 | 26 |
| 2018 | 1 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 1 | — | 0 | 10 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K810258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K810258: Proximal Fermoral Hip Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810258
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026