510(k) · Cleared
ClearedHowmedics DRG Femoral Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Oct 20, 1994 after a 301-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 302 later devices descend from it.
- Decided
- Oct 20, 1994
- Review
- 301 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
302 later devices descend from it, 4 citing it directly.
- This deviceK936126 Howmedics DRG Femoral ComponentHowmedica, Inc. · 1994
- Descendant · cites it directly · 298 of its ownK022077 36MM V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. · 2002 · Recalled
- Descendant · 2 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- Descendant · 2 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004
- Descendant · 4 generations on · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
Showing 5 of 302 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 302 · See all- K02207736MM V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. · 2002 · cites it directly298descendants
- K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 2 generations on267descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 2 generations on198descendants
- K043079Bicontact Hip System with U-CapAesculap · 2004 · 3 generations on166descendants
- K093472Trinity Acetabular SystemCorin USA · 2010 · 4 generations on117descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936126 | Howmedics DRG Femoral Component | Howmedica, Inc. | 1994 | — |
| +1 | K022077 | 36MM V40 Femoral Head Components (Lfit and Non-Lfit) | Howmedica Osteonics Corp. | 2002 | 12 |
| +2 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| +2 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +3 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| +4 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 16 | 0 |
| 2012 | 22 | 0 |
| 2013 | 21 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 12 | 0 |
| 2017 | 17 | 0 |
| 2018 | 18 | 0 |
| 2019 | 17 | 0 |
| 2020 | 17 | 0 |
| 2021 | 20 | 0 |
| 2022 | 22 | 0 |
| 2023 | 18 | 0 |
| 2024 | 15 | 0 |
| 2025 | 22 | 0 |
| 2026 | 19 | 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? (302)
See all 3024 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?
- Of its descendants, K022077 (Howmedica Osteonics Corp., 2002) has gone furthest, with 298 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/K936126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K936126: Howmedics DRG Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K936126
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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