510(k) · Cleared
ClearedCompetitor Unicondylar All-Poly Tibial Baseplate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Aug 4, 2006 as substantially equivalent to K912735 (Smith & Nephew Richards, Inc., 1991) and 2 other predicates after a 39-day review. Its family tree reaches back 2 generations to 1993. 5 later devices descend from it.
- Decided
- Aug 4, 2006
- Review
- 39 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K923011 (1993). 7 ancestors in all, the oldest K760245 (1976). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK923011 Osteonics Unix UnicompartmentalOsteonics Corp. · 1993
- 1 generation backK033769 Eius Unicompartmental Knee SystemHowmedica Osteonics Corp. · 2004
- This deviceK061779 Competitor Unicondylar All-Poly Tibial BaseplateSmith & Nephew, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK242711 JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK113038 Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee…Smith & Nephew, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
- K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 2 generations on0descendants
- K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024 · 2 generations on0descendants
- K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024 · 2 generations on0descendants
- K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923011 | Osteonics Unix Unicompartmental | Osteonics Corp. | 1993 | — |
| −1 | K033769 | Eius Unicompartmental Knee System | Howmedica Osteonics Corp. | 2004 | — |
| 0 (this device) | K061779 | Competitor Unicondylar All-Poly Tibial Baseplate | Smith & Nephew, Inc. | 2006 | — |
| +1 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +2 | K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026 | — |
| +2 | K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | 2024 | — |
| +2 | K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | 2024 | — |
| +1 | K113038 | Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System… | Smith & Nephew, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 HSX? 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 HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K912735 | Genesis Unicompartmental Knee SystemSummary page 1…are based upon the existing Genesis Unicompartmental tibial implants and the existing Mod IIKnee System implants cleared under 510(k) Notifications K912735 and K760245, respectively. C. SUBSTANTIAL EoUIVALENCE INFORMATION: The Smith & Nephew Competitor Unicon… | 1991 |
| * | K033769 | Eius Unicompartmental Knee SystemSummary page 1…dications, and materials: * Smith & Nephew Genesis Unicompartmental Knee System (K912735) * Howmedica Osteonics EIUS Unicompartmental Knee System (K033769) * Smith & Nephew Mod 11Knee System (K760245) DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2004 |
| * | K760245 | Prosthesis, Richards Mod II KneeSummary page 1…on the existing Genesis Unicompartmental tibial implants and the existing Mod IIKnee System implants cleared under 510(k) Notifications K912735 and K760245, respectively. C. SUBSTANTIAL EoUIVALENCE INFORMATION: The Smith & Nephew Competitor Unicondylar AII-Po… | 1976 |
What descends from it? (5)
2 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K230653 (Smith & Nephew, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K912735.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, 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 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Competitor Unicondylar All-Poly Tibial Baseplate Components are indicated for restoring either compartment of a knee that has been affected by the following:
* Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
* correction of functional deformity;
* revision procedures where other treatments or devices have failed; and
* treatment of fractures that are unmanageable using other techniques
The all-poly baseplate components are for single use only and are intended for implantation only with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061779 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061779: Competitor Unicondylar All-Poly Tibial Baseplate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061779
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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