510(k) · Cleared
Recalled · Class II · 2015Lfit V40 Femoral Head Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Apr 11, 2001 as substantially equivalent to K910988 (Osteonics Corp., 1991) after a 29-day review. Its family tree reaches back 1 generation to 1991. 300 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 11, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910988 (1991). 300 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK910988 Osteonics Ion Implanted Femoral Bearing SeriesOsteonics Corp. · 1991
- This deviceK010757 Lfit V40 Femoral Head ComponentsHowmedica Osteonics Corp. · 2001
- 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 300 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 300 · 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 |
|---|---|---|---|---|---|
| −1 | K910988 | Osteonics Ion Implanted Femoral Bearing Series | Osteonics Corp. | 1991 | — |
| 0 (this device) | K010757 | Lfit V40 Femoral Head Components | Howmedica Osteonics Corp. | 2001 | — |
| +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 | 19 | 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 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? (1)
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 |
|---|---|---|---|
| * | K910988 | Osteonics Ion Implanted Femoral Bearing SeriesSummary page 1…device are identical to those of predicate devices. The predicate ion implanted femoral bearing components were found substantially equivalent via the 510(k) process in K910988. The V40™ femoral head components were cleared in 510(k) numbers: K936126, K950541, and K993601. The predicate ion implanted devi… | 1991 |
What descends from it? (300)
See all 3005 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 |
|---|---|---|---|---|
| Feb 3, 2015 | Class II | Z-1241-2015 | Under Investigation by firm | Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion. |
| 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. |
| Nov 2, 2007 | Not classified | Z-0962-2008 | Other | Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
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/K010757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010757: Lfit V40 Femoral Head Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010757
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026