510(k) · Cleared
ClearedZirconium Alloy Uni-Polar Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Apr 25, 1994 after a 229-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.
- Decided
- Apr 25, 1994
- Review
- 229 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 3 citing it directly.
- This deviceK934353 Zirconium Alloy Uni-Polar HeadSmith & Nephew Richards, Inc. · 1994
- Descendant · cites it directly · 16 of its ownK093363 Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010
- Descendant · 2 generations on · 7 of its ownK113848 R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 6 of its ownK161233 OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016
- Descendant · 2 generations on · 6 of its ownK102370 R3 Xlpe Anteverted LinersSmith & Nephew, Inc. · 2011
- Descendant · 3 generations on · 5 of its ownK191002 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010 · cites it directly16descendants
- K113848R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · 2 generations on7descendants
- K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016 · 2 generations on6descendants
- K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc. · 2011 · 2 generations on6descendants
- K191002OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934353 | Zirconium Alloy Uni-Polar Head | Smith & Nephew Richards, Inc. | 1994 | — |
| +1 | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | Smith & Nephew, Inc. | 2010 | — |
| +2 | K113848 | R3 Xlpe Liners | Smith & Nephew, Inc. | 2012 | 2 |
| +2 | K161233 | OXINIUM DH Fermoral Heads | Smith & Nephew, Inc. | 2016 | — |
| +2 | K102370 | R3 Xlpe Anteverted Liners | Smith & Nephew, Inc. | 2011 | — |
| +3 | K191002 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
Planning a device in KWL? 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 KWL device
- #1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 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? (17)
See all 173 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, K093363 (Smith & Nephew, Inc., 2010) has gone furthest, with 16 descendants of its own.
How does its category compare?
All KWL devicesKWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWL
32in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWL
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWL
29in 2025
MAUDE reports naming product code KWL, 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 | 2 | — | 36 | 11 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 2 | 21 |
| 2010 | 0 | — | 0 | 55 |
| 2011 | 2 | — | 0 | 51 |
| 2012 | 1 | — | 0 | 62 |
| 2013 | 0 | — | 0 | 89 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 1 | — | 1 | 223 |
| 2016 | 0 | — | 0 | 210 |
| 2017 | 0 | — | 2 | 347 |
| 2018 | 2 | — | 0 | 294 |
| 2019 | 1 | — | 0 | 415 |
| 2020 | 1 | — | 0 | 270 |
| 2021 | 0 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 99 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 1 | — | 0 | 143 |
| 2025 | 3 | 32 | 0 | 29 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K934353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934353: Zirconium Alloy Uni-Polar Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934353
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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