510(k) · Cleared
ClearedHowmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Feb 11, 2005 as substantially equivalent to K971409 (Osteonics Corp., 1997) and 3 other predicates after a 207-day review. Its family tree reaches back 2 generations to 1997. 18 later devices descend from it.
- Decided
- Feb 11, 2005
- Review
- 207 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K971409 (1997). 7 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK971409 Osteonics Alumina C-Taper HeadOsteonics Corp. · 1997
- 1 generation backK991952 Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene InsertsHowmedica Osteonics Corp. · 1999
- This deviceK041940 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 · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- Descendant · 2 generations on · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
- Descendant · 2 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
- Descendant · 2 generations on · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
- K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 2 generations on8descendants
- K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 2 generations on7descendants
- K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 2 generations on6descendants
- K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971409 | Osteonics Alumina C-Taper Head | Osteonics Corp. | 1997 | — |
| −1 | K991952 | Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts | Howmedica Osteonics Corp. | 1999 | — |
| 0 (this device) | 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 |
| +2 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
| +2 | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II… | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019 | — |
| +2 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022 | — |
| +2 | K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K971409 | Osteonics Alumina C-Taper HeadSummary page 1…December 1, 2004 Predicate Devices The predicate devices cited in this 510(k) application are the Osteonics® Alumina C-Taper Heads cleared under K971409, K991952, and K003391, and the competitive ceramic heads cleared under K031803. Device Description The subject Zirconia-Toughene… | 1997 |
| * | K991952 | Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene InsertsSummary page 1…December 1, 2004 Predicate Devices The predicate devices cited in this 510(k) application are the Osteonics® Alumina C-Taper Heads cleared under K971409, K991952, and K003391, and the competitive ceramic heads cleared under K031803. Device Description The subject Zirconia-Toughened-Alumina… | 1999 |
| * | K003391 | Osteonics Alumina C-Taper HeadSummary page 1…December 1, 2004 Predicate Devices The predicate devices cited in this 510(k) application are the Osteonics® Alumina C-Taper Heads cleared under K971409, K991952, and K003391, and the competitive ceramic heads cleared under K031803. Device Description The subject Zirconia-Toughened-Alumina (ZTA) Cerami… | 2000 |
| * | K031803 | Depuy Ceramic Femoral HeadsSummary page 1…es cited in this 510(k) application are the Osteonics® Alumina C-Taper Heads cleared under K971409, K991952, and K003391, and the competitive ceramic heads cleared under K031803. Device Description The subject Zirconia-Toughened-Alumina (ZTA) Ceramic Femoral Heads feature: * Biolox® Delta material: this m… | 2003 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 | 17 |
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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K153345 (Stryker Orthopaedics, 2016) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K971409.
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 subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene bearing surfaces. Indications for Use as a Bipolar • Femoral…
Read the full statement (238 words)
The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene bearing surfaces.
Indications for Use as a Bipolar
• 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.
• Pathological conditions or age considerations that indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum,
* Salvage of failed total hip arthroplasty
Indications for Use as a Total Hip:
* Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
* Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
* Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results,
* Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
* The term "C-Taper" includes both the original C-Taper design, and the modified C-Taper design first introduced on the hip stems found Substantially Equivalent via K982032
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041940 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041940: Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041940
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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