510(k) · Cleared
ClearedDepuy Femoral Heads
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 Jan 28, 2002 after a 255-day review. The FDA summary names its predicate without a number. 378 later devices descend from it.
- Decided
- Jan 28, 2002
- Review
- 255 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 0
378 later devices descend from it, 4 citing it directly.
- This deviceK011533 Depuy Femoral HeadsDePuy Orthopaedics, Inc. · 2002
- Descendant · cites it directly · 377 of its ownK031803 Depuy Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 2003
- Descendant · 2 generations on · 345 of its ownK042091 Biolox Delta Ceramic HeadsBiomet, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- Descendant · 2 generations on · 222 of its ownK040644 Modification to Depuy Ceramic Femoral HeadDePuy Orthopaedics, Inc. · 2004
Showing 5 of 378 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 378 · See all- K031803Depuy Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 2003 · cites it directly377descendants
- K042091Biolox Delta Ceramic HeadsBiomet, Inc. · 2005 · 2 generations on345descendants
- K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · 3 generations on344descendants
- K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006 · 3 generations on343descendants
- K040644Modification to Depuy Ceramic Femoral HeadDePuy Orthopaedics, Inc. · 2004 · 2 generations on222descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011533 | Depuy Femoral Heads | DePuy Orthopaedics, Inc. | 2002 | — |
| +1 | K031803 | Depuy Ceramic Femoral Heads | DePuy Orthopaedics, Inc. | 2003 | — |
| +2 | K042091 | Biolox Delta Ceramic Heads | Biomet, Inc. | 2005 | 2 |
| +3 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| +3 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| +2 | K040644 | Modification to Depuy Ceramic Femoral Head | DePuy Orthopaedics, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 13 | 0 |
| 2012 | 17 | 0 |
| 2013 | 20 | 0 |
| 2014 | 17 | 0 |
| 2015 | 17 | 0 |
| 2016 | 16 | 0 |
| 2017 | 15 | 0 |
| 2018 | 21 | 0 |
| 2019 | 33 | 0 |
| 2020 | 26 | 0 |
| 2021 | 21 | 0 |
| 2022 | 25 | 0 |
| 2023 | 22 | 0 |
| 2024 | 29 | 0 |
| 2025 | 30 | 0 |
| 2026 | 27 | 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? (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 |
|---|---|---|---|
| * | — | Ceramic ArticuVeze Femoral Balls Named without a submission number | |
| * | — | S-ROM Ceramic Femoral Heads Named without a submission number |
What descends from it? (378)
See all 3784 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, K031803 (DePuy Orthopaedics, Inc., 2003) has gone furthest, with 377 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?
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…
Read the full statement (103 words)
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/K011533 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011533: Depuy Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011533
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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