510(k) · Cleared
ClearedConical Collar Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kirschner Medical Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Nov 19, 1985 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 210 later devices descend from it.
- Decided
- Nov 19, 1985
- Review
- 48 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
210 later devices descend from it, 1 citing it directly.
- This deviceK854046 Conical Collar Hip ProsthesisKirschner Medical Corp. · 1985
- Descendant · cites it directly · 209 of its ownK960303 Fenning Femoral ComponentBiomet, Inc. · 1996
- Descendant · 2 generations on · 208 of its ownK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 160 of its ownK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
- Descendant · 3 generations on · 138 of its ownK050124 Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 137 of its ownK070369 Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · Recalled
Showing 5 of 210 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 210 · See all- K960303Fenning Femoral ComponentBiomet, Inc. · 1996 · cites it directly209descendants
- K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…Biomet, Inc. · 2003 · 2 generations on208descendants
- K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005 · 3 generations on160descendants
- K050124Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · 3 generations on138descendants
- K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · 4 generations on137descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854046 | Conical Collar Hip Prosthesis | Kirschner Medical Corp. | 1985 | — |
| +1 | K960303 | Fenning Femoral Component | Biomet, Inc. | 1996 | — |
| +2 | K030055 | Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric… | Biomet, Inc. | 2003 | 3 |
| +3 | K043537 | Taperloc 12/14 Taper Femoral Components | Biomet, Inc. | 2005 | — |
| +3 | K050124 | Porous Coated Acetabular Components | Biomet, Inc. | 2005 | 1 |
| +4 | K070369 | Regenerx Ringloc + Modular Acetabular Shells | Biomet, Inc. | 2007 | 19 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 15 | 0 |
| 2013 | 10 | 0 |
| 2014 | 16 | 0 |
| 2015 | 11 | 0 |
| 2016 | 9 | 0 |
| 2017 | 12 | 0 |
| 2018 | 7 | 0 |
| 2019 | 21 | 0 |
| 2020 | 8 | 0 |
| 2021 | 8 | 0 |
| 2022 | 12 | 0 |
| 2023 | 14 | 0 |
| 2024 | 13 | 0 |
| 2025 | 16 | 0 |
| 2026 | 17 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (210)
See all 2101 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960303 | Fenning Femoral Component | 1996 | 209 |
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, K960303 (Biomet, Inc., 1996) has gone furthest, with 209 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 | — |
https://510kreport.com/device/K854046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K854046: Conical Collar Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K854046
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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