510(k) · Cleared
ClearedZirconia Ceramic Modular Heads (Norton Advanced Ceramics)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Aug 11, 1997 after a 279-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Aug 11, 1997
- Review
- 279 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK964431 Zirconia Ceramic Modular Heads (Norton Advanced Ceramics)Biomet, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK991708 Zirconia 22.22MM Ceramic Modular HeadsBiomet, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K991708Zirconia 22.22MM Ceramic Modular HeadsBiomet, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964431 | Zirconia Ceramic Modular Heads (Norton Advanced Ceramics) | Biomet, Inc. | 1997 | — |
| +1 | K991708 | Zirconia 22.22MM Ceramic Modular Heads | Biomet, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 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? (7)
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 |
|---|---|---|---|
| * | — | Zirconia Ceramic Heads (Type I Taper) (Biomet, Warsaw, IN) Named without a submission number | |
| * | — | Zirconia Femoral Heads (Smith & Nephew Richards, Memphis, TN) Named without a submission number | |
| * | — | Biolox® Al₂O₃ Ceramic Femoral Heads (Dow Corning Wright, Arlington, TN) Named without a submission number | |
| * | — | Biolox® Al₂O₃ Ceramic Femoral Heads (Smith and Nephew Richards, Memphis, TN) Named without a submission number | |
| * | — | Modular Ceramic Heads (DePuy, Warsaw, IN) Named without a submission number | |
| * | — | Modular Ceramic Heads (Thackray, Orlando, FL) Named without a submission number | |
| * | — | Modular Ceramic Heads (Protek, Indianapolis, IN) Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991708 | Zirconia 22.22MM Ceramic Modular Heads | 1999 | 0 |
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, K991708 (Biomet, Inc., 1999) has gone furthest, with 0 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 (Norton Advanced Ceramics) are indicated for use in Non-inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis, Rheumatoid Arthritis, correction of functional deformity, and revision of failed hip arthroplasty.
This device is a single use implant.
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/K964431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964431: Zirconia Ceramic Modular Heads (Norton Advanced Ceramics).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964431
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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