510(k) · Cleared
Recalled · 2009Howmedica Osteonics Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Nov 16, 1999 after a 22-day review. The FDA summary names its predicate without a number. 299 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 16, 1999
- Review
- 22 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- 3
- Predicates
- 0
299 later devices descend from it, 4 citing it directly.
- This deviceK993601 Howmedica Osteonics Femoral HeadsHowmedica Osteonics Corp. · 1999
- 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 299 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 299 · 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) | K993601 | Howmedica Osteonics Femoral Heads | Howmedica Osteonics Corp. | 1999 | — |
| +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 |
|---|---|---|
| 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), 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 LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | V40™ femoral heads Named without a submission number | |
| * | — | P.C.A.® femoral heads Named without a submission number |
What descends from it? (299)
See all 2994 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2009 | Not classified | Z-0390-2010 | Process control | Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head. |
| Sep 4, 2009 | Not classified | Z-0391-2010 | Process control | Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head. |
| Jun 18, 2009 | Not classified | Z-1822-2009 | Process control | Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width. |
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 LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWJ
Too few LWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 2025
MAUDE reports naming product code LWJ, 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 | 2 | — | 10 | 68 |
| 2008 | 1 | — | 2 | 72 |
| 2009 | 1 | — | 2 | 84 |
| 2010 | 0 | — | 0 | 132 |
| 2011 | 1 | — | 0 | 255 |
| 2012 | 1 | — | 0 | 390 |
| 2013 | 0 | — | 1 | 522 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 310 |
| 2016 | 0 | — | 0 | 293 |
| 2017 | 0 | — | 0 | 311 |
| 2018 | 0 | — | 0 | 227 |
| 2019 | 0 | — | 0 | 210 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 155 |
| 2022 | 0 | — | 0 | 91 |
| 2023 | 0 | — | 2 | 72 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
These devices are modular components of a total hip system. These femoral heads are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
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/K993601 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993601: Howmedica Osteonics Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993601
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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