510(k) · Cleared
ClearedModification to Depuy Ceramic Femoral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Apr 8, 2004 as substantially equivalent to K031803 (DePuy Orthopaedics, Inc., 2003) after a 28-day review. Its family tree reaches back 2 generations to 2002. 222 later devices descend from it.
- Decided
- Apr 8, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011533 (2002). 222 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK011533 Depuy Femoral HeadsDePuy Orthopaedics, Inc. · 2002
- 1 generation backK031803 Depuy Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 2003
- This deviceK040644 Modification to Depuy Ceramic Femoral HeadDePuy Orthopaedics, Inc. · 2004
- Descendant · cites it directly · 219 of its ownK062748 Modification: to Depuy Delta Ceramic Femoral HeadDePuy Orthopaedics, Inc. · 2006
- Descendant · 2 generations on · 217 of its ownK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 165 of its ownK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- Descendant · 3 generations on · 149 of its ownK083762 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009
- Descendant · 3 generations on · 140 of its ownK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
Showing 5 of 222 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 222 · See all- K062748Modification: to Depuy Delta Ceramic Femoral HeadDePuy Orthopaedics, Inc. · 2006 · cites it directly219descendants
- K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · 2 generations on217descendants
- K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P. · 2008 · 2 generations on165descendants
- K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009 · 3 generations on149descendants
- K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010 · 3 generations on140descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011533 | Depuy Femoral Heads | DePuy Orthopaedics, Inc. | 2002 | — |
| −1 | K031803 | Depuy Ceramic Femoral Heads | DePuy Orthopaedics, Inc. | 2003 | — |
| 0 (this device) | K040644 | Modification to Depuy Ceramic Femoral Head | DePuy Orthopaedics, Inc. | 2004 | — |
| +1 | K062748 | Modification: to Depuy Delta Ceramic Femoral Head | DePuy Orthopaedics, Inc. | 2006 | — |
| +2 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| +2 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| +3 | K083762 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2009 | — |
| +3 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 10 | 0 |
| 2012 | 8 | 0 |
| 2013 | 18 | 0 |
| 2014 | 10 | 0 |
| 2015 | 10 | 0 |
| 2016 | 12 | 0 |
| 2017 | 14 | 0 |
| 2018 | 13 | 0 |
| 2019 | 17 | 0 |
| 2020 | 15 | 0 |
| 2021 | 10 | 0 |
| 2022 | 14 | 0 |
| 2023 | 14 | 0 |
| 2024 | 14 | 0 |
| 2025 | 19 | 0 |
| 2026 | 12 | 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 |
|---|---|---|---|
| * | K031803 | Depuy Ceramic Femoral HeadsSummary page 1…Class 11 DEVICE PRODUCT CODE: 87 LZO SUBSTANTIALLY EQUIVALENT DEVICE: DePuy Ceramic Femoral Heads, K03 1803 DEVICE DESCRIPTION AND INTENDED USE: The DePuy Ceramic Femoral Head is composed of an alumina composite material and is availab… | 2003 |
What descends from it? (222)
See all 2223 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?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062748 (DePuy Orthopaedics, Inc., 2006) has gone furthest, with 219 descendants of its own.
- 8 other devices also cite its predicate K031803.
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 DePuy Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled…
Read the full statement (122 words)
The DePuy Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040644 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040644: Modification to Depuy Ceramic Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040644
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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