510(k) · Cleared
ClearedOsteonics Alumina C-Taper Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jul 9, 1997 after an 84-day review. The FDA summary names its predicate without a number. 31 later devices descend from it.
- Decided
- Jul 9, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 4 citing it directly.
- This deviceK971409 Osteonics Alumina C-Taper HeadOsteonics Corp. · 1997
- Descendant · cites it directly · 20 of its ownK991952 Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene InsertsHowmedica Osteonics Corp. · 1999
- Descendant · cites it directly · 18 of its ownK041940 Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta)…Howmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · cites it directly · 9 of its ownK990261 Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999
- Descendant · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K991952Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene InsertsHowmedica Osteonics Corp. · 1999 · cites it directly20descendants
- K041940Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral HeadsHowmedica Osteonics Corp. · 2005 · cites it directly18descendants
- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
- K990261Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999 · cites it directly9descendants
- K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971409 | Osteonics Alumina C-Taper Head | Osteonics Corp. | 1997 | — |
| +1 | K991952 | Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts | Howmedica Osteonics Corp. | 1999 | — |
| +1 | K041940 | Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral… | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +1 | K990261 | Plus Ceramic Head Prostheses (Alumina and Zirkonia) | Plus Orthopedics | 1999 | — |
| +2 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | — | Osteonics® Omnifit® Ceramic Morse Taper Head Named without a submission number | |
| * | — | Osteonics® Zirconia C-Taper Femoral Bearing Head Named without a submission number | |
| * | — | Osteonics® Alumina Ceramic Bearing Head and Titanium Adaptor Sleeve Assembly Named without a submission number | |
| * | — | Osteonics® C-Taper Zirconia Ceramic Head Named without a submission number |
What descends from it? (31)
See all 314 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991952 | Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts | 1999 | 20 |
| K041940 | Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral Heads | 2005 | 18 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 | 17 |
| K990261 | Plus Ceramic Head Prostheses (Alumina and Zirkonia) | 1999 | 9 |
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, K991952 (Howmedica Osteonics Corp., 1999) has gone furthest, with 20 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 indications for the use: of -these ceramic bearings; in keeping with those of other legally marketed Osteonics ceramic bearings, are as follows: For Use as a Bipolar Hip Replacement: Femoral head/neck fractures or non-unions. Aseptic necrosis of the femoral head. Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations: Pathological conditions or age considerations which…
Read the full statement (139 words)
The indications for the use: of -these ceramic bearings; in keeping with those of other legally marketed Osteonics ceramic bearings, are as follows:
For Use as a Bipolar Hip Replacement:
Femoral head/neck fractures or non-unions.
Aseptic necrosis of the femoral head.
Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
Pathological conditions or age considerations which indicate a more conservative acetabular procedure and in avoidance of the use of bone cement in the acetabulum.
Salvage of failed total hip arthroplasty.
For Use as a Total Hip Replacement:
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
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/K971409 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971409: Osteonics Alumina C-Taper Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971409
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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