510(k) · Cleared
ClearedUnicondylar Femoral Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Feb 25, 2003 after a 27-day review. The FDA summary names its predicate without a number. 30 later devices descend from it.
- Decided
- Feb 25, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 4 citing it directly.
- This deviceK030301 Unicondylar Femoral ComponentSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 26 of its ownK073175 Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2007
- Descendant · 2 generations on · 18 of its ownK081351 Modification to Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2008
- Descendant · cites it directly · 11 of its ownK061011 Competitor Unicondylar Knee Tibial BaseplateSmith & Nephew, Inc. · 2006
- Descendant · 3 generations on · 8 of its ownK163700 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017
- Descendant · 3 generations on · 8 of its ownK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K073175Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2007 · cites it directly26descendants
- K081351Modification to Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2008 · 2 generations on18descendants
- K061011Competitor Unicondylar Knee Tibial BaseplateSmith & Nephew, Inc. · 2006 · cites it directly11descendants
- K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017 · 3 generations on8descendants
- K160738ZUK Select Knee SystemSmith & Nephew, Inc. · 2016 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030301 | Unicondylar Femoral Component | Smith & Nephew, Inc. | 2003 | — |
| +1 | K073175 | Journey Unicondylar Femoral Implant | Smith & Nephew, Inc. | 2007 | — |
| +2 | K081351 | Modification to Journey Unicondylar Femoral Implant | Smith & Nephew, Inc. | 2008 | — |
| +1 | K061011 | Competitor Unicondylar Knee Tibial Baseplate | Smith & Nephew, Inc. | 2006 | — |
| +3 | K163700 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2017 | — |
| +3 | K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 7 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Existing components distributed by Smith & Nephew, Inc. Named without a submission number |
What descends from it? (30)
See all 304 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073175 | Journey Unicondylar Femoral Implant | 2007 | 26 |
| K061011 | Competitor Unicondylar Knee Tibial Baseplate | 2006 | 11 |
| K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and… | 2023 | 3 |
| K113038 | Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System Instruments | 2012 | 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, K073175 (Smith & Nephew, Inc., 2007) has gone furthest, with 26 descendants of its own.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
The Unicondylar Femoral Components are indicated for restoring either compartment of a knee that has been affected by the following:
5) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
6) correction of functional deformity;
7) revision procedures where other treatments or devices have failed; and
8) treatment of fractures that are unmanageable using other techniques.
The Unicondylar Femoral Components are single use only and are intended for implantation with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030301: Unicondylar Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030301
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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