510(k) · Cleared
ClearedCeramic Femoral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dow Corning Wright · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 26, 1989 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 16 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.
- Decided
- Sep 26, 1989
- Review
- 133 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- This deviceK893685 Ceramic Femoral HeadDow Corning Wright · 1989
- Descendant · cites it directly · 14 of its ownK100866 Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 8 of its ownK112080 Preserve Hip StemWrightmedicaltechnologyinc · 2011
- Descendant · 2 generations on · 5 of its ownK111910 Gladiator Hip StemWrightmedicaltechnologyinc · 2011
- Descendant · 3 generations on · 4 of its ownK150302 PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK112150 Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc · 2011
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100866 Profemur Hip System Modular Neckscites it directly · 2010
Most influential descendants
Showing 5 of 15 · See all- K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · cites it directly14descendants
- K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011 · 2 generations on8descendants
- K111910Gladiator Hip StemWrightmedicaltechnologyinc · 2011 · 2 generations on5descendants
- K150302PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc. · 2015 · 3 generations on4descendants
- K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc · 2011 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K893685 | Ceramic Femoral Head | Dow Corning Wright | 1989 | — |
| +1 | K100866 | Profemur Hip System Modular Necks | Wrightmedicaltechnologyinc | 2010 | Class I |
| +2 | K112080 | Preserve Hip Stem | Wrightmedicaltechnologyinc | 2011 | — |
| +2 | K111910 | Gladiator Hip Stem | Wrightmedicaltechnologyinc | 2011 | — |
| +3 | K150302 | PROFEMUR Preserve Classic Stem | Microport Orthopedics, Inc. | 2015 | — |
| +2 | K112150 | Profemur Gladiator HA Hip Stem | Wrightmedicaltechnologyinc | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 1 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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.
1 device in this family has a Class I recall. 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? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K100866 (Wrightmedicaltechnologyinc, 2010) has gone furthest, with 14 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/K893685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K893685: Ceramic Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K893685
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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