510(k) · Cleared
ClearedZyranox Zirconia Ceramic Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Nov 23, 1999 after a 144-day review. The FDA summary names no predicate by number. 119 later devices descend from it.
- Decided
- Nov 23, 1999
- Review
- 144 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 0
119 later devices descend from it, 3 citing it directly.
- This deviceK992235 Zyranox Zirconia Ceramic Femoral HeadsCorin USA · 1999
- Descendant · cites it directly · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
- Descendant · cites it directly · 110 of its ownK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- Descendant · cites it directly · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- Descendant · 2 generations on · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
- Descendant · 3 generations on · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 119 · See all- K093472Trinity Acetabular SystemCorin USA · 2010 · cites it directly117descendants
- K103120Corin Biolox Delta Femoral HeadsCorin USA · 2011 · cites it directly110descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · cites it directly109descendants
- K111911Corin Optimom Modular HeadCorin USA · 2011 · 2 generations on62descendants
- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · 3 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992235 | Zyranox Zirconia Ceramic Femoral Heads | Corin USA | 1999 | — |
| +1 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
| +1 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| +1 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| +2 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| +3 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 12 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 10 | 0 |
| 2019 | 9 | 0 |
| 2020 | 10 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 10 | 0 |
| 2024 | 7 | 0 |
| 2025 | 12 | 0 |
| 2026 | 10 | 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?
The FDA summary names no predicate by number.
What descends from it? (119)
See all 1193 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, K093472 (Corin USA, 2010) has gone furthest, with 117 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 Zirconia Ceramic Modular Heads are used in combination with femoral hip stems and
ultra high molecular weight polyethylene (UHMWPE) acetabular cups or acetabular cup
liners to reinstate function following the degenerative effects of ostco or rheumatoid arthritis,
post-trauma disease cffects, avascular necrosis and septic or aseptic total hip revision.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992235: Zyranox Zirconia 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/K992235
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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