510(k) · Cleared
ClearedHLS Uni Evolution & U-Kneetec
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Jul 25, 2012 as substantially equivalent to K022211 (Tornier, 2003) and 2 other predicates after a 180-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Jul 25, 2012
- Review
- 180 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K881779 (1988). 8 ancestors in all, the oldest K880155 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK881779 Whiteside Ortholoc II Unicondylar Knee SystemDow Corning Wright · 1988
- 2 generations backK014171 Advance Unicondylar Knee SystemWrightmedicaltechnologyinc · 2002
- 1 generation backK022211 HLS Uni Evolution ProsthesisTornier · 2003
- This deviceK120262 HLS Uni Evolution & U-KneetecTornier, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881779 | Whiteside Ortholoc II Unicondylar Knee System | Dow Corning Wright | 1988 | — |
| −2 | K014171 | Advance Unicondylar Knee System | Wrightmedicaltechnologyinc | 2002 | — |
| −1 | K022211 | HLS Uni Evolution Prosthesis | Tornier | 2003 | — |
| 0 (this device) | K120262 | HLS Uni Evolution & U-Kneetec | Tornier, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 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 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 |
|---|---|---|---|
| * | K022211 | HLS Uni Evolution ProsthesisSummary page 3…Tomnier Torrier Zimmer -numrber pending j K022211 K880155 and K942263 The indications for use, the technical characteristics (materials, manufacturing princi… | 2003 |
| * | K880155 | Miller/Galante Precoat Unicompartmental KneeSummary page 2…___________ 6) Equivalent / Predicate device HLS Uni Evolution, Terrier, K0222l11 M!C Miller-Galante Unicomparimental Knee System, Zimmer, Inc., K880155 and K942263 7) Device description The usual goal of a unicompartmental knee prosthesis is to restore the knee joi… | 1988 |
| * | K942263 | Miller/Galante Precoat Unicompartmental Knee SystemSummary page 2…__ 6) Equivalent / Predicate device HLS Uni Evolution, Terrier, K0222l11 M!C Miller-Galante Unicomparimental Knee System, Zimmer, Inc., K880155 and K942263 7) Device description The usual goal of a unicompartmental knee prosthesis is to restore the knee joint to its be… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 9.2 years on median.
- 3 of the 8 ancestors have a recall of any class.
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. 2012, this device’s year, is highlighted.
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 HLS Uni Evolution and U-KneeTec unicompartmental knee prostheses are indicated for the replacement of the medial or lateral compartment of the femorotibial knee joint when only one compartment is affected, in order to reduce pain and restore knee function in comparison with preoperative status.
These devices are indicated in the treatment of primary or secondary femorotibial osteoarthritis. The HLS Uni Evolution and U-KneeTec knee prostheses are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120262: HLS Uni Evolution & U-Kneetec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120262
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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