510(k) · Cleared
Recalled · Class II · 2022V40 Biolox Delta Ceramic Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Oct 27, 2005 after a 28-day review. The FDA summary names its predicate without a number. 186 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 27, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 2
- Predicates
- 0
186 later devices descend from it, 6 citing it directly.
- This deviceK052718 V40 Biolox Delta Ceramic Femoral HeadsHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 165 of its ownK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- Descendant · 2 generations on · 140 of its ownK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- Descendant · 3 generations on · 110 of its ownK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- Descendant · 3 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- Descendant · 4 generations on · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
Showing 5 of 186 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 186 · See all- K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P. · 2008 · cites it directly165descendants
- K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010 · 2 generations on140descendants
- K103120Corin Biolox Delta Femoral HeadsCorin USA · 2011 · 3 generations on110descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 3 generations on109descendants
- K111911Corin Optimom Modular HeadCorin USA · 2011 · 4 generations on62descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052718 | V40 Biolox Delta Ceramic Femoral Heads | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| +2 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| +3 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| +3 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| +4 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 15 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 10 | 0 |
| 2017 | 11 | 0 |
| 2018 | 14 | 0 |
| 2019 | 14 | 0 |
| 2020 | 13 | 0 |
| 2021 | 11 | 0 |
| 2022 | 15 | 0 |
| 2023 | 14 | 0 |
| 2024 | 13 | 0 |
| 2025 | 17 | 0 |
| 2026 | 11 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 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 |
|---|---|---|---|
| * | — | Alumina V40 Ceramic Femoral Heads Named without a submission number |
What descends from it? (186)
See all 1866 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve | 2008 | 165 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 | 17 |
| K071830 | Depuy Delta TS Ceramic Femoral Heads | 2007 | 14 |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | 2020 | 6 |
| K234025 | 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads | 2024 | 0 |
| K173380 | b-ONE® Total Hip System | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2022 | Class II | Z-0842-2022 | Under Investigation by firm | Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling |
| Jan 14, 2022 | Class II | Z-0843-2022 | Under Investigation by firm | Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082844 (Encore Medical L.P., 2008) has gone furthest, with 165 descendants of its own.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' ceramic femoral bearing heads are as follows: For Use as a Total Hip Replacement: * Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis. * Revision of previous cup arthroplasty or other procedures * Clinical management problems…
Read the full statement (149 words)
The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' ceramic femoral bearing heads are as follows:
For Use as a Total Hip Replacement:
* Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis.
* Revision of previous cup arthroplasty or other procedures
* Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement
* Femoral head/neck fractures or non-unions.
* Asceptic necrosis of the femoral head.
* Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
* Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
* Salvage of failed total hip arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052718: V40 Biolox Delta Ceramic 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/K052718
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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