510(k) · Cleared
ClearedZimmer Ceramic Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Mar 7, 1991 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 92 later devices descend from it.
- Decided
- Mar 7, 1991
- Review
- 73 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 0
92 later devices descend from it, 1 citing it directly.
- This deviceK905739 Zimmer Ceramic Femoral HeadsZimmer, Inc. · 1991
- Descendant · cites it directly · 91 of its ownK030724 Alumina Ceramic Femoral Heads, 28 and 32 MMZimmer, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- Descendant · 3 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- Descendant · 3 generations on · 65 of its ownK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- Descendant · 3 generations on · 63 of its ownK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 92 · See all- K030724Alumina Ceramic Femoral Heads, 28 and 32 MMZimmer, Inc. · 2003 · cites it directly91descendants
- K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · 2 generations on90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 3 generations on83descendants
- K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006 · 3 generations on65descendants
- K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008 · 3 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905739 | Zimmer Ceramic Femoral Heads | Zimmer, Inc. | 1991 | — |
| +1 | K030724 | Alumina Ceramic Femoral Heads, 28 and 32 MM | Zimmer, Inc. | 2003 | 7 |
| +2 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| +3 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +3 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| +3 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 11 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (92)
See all 921 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030724 | Alumina Ceramic Femoral Heads, 28 and 32 MM | 2003 | 91 |
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, K030724 (Zimmer, Inc., 2003) has gone furthest, with 91 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 | — |
https://510kreport.com/device/K905739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905739: Zimmer 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/K905739
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026