510(k) · Cleared
ClearedHLS Uni Evolution Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on May 22, 2003 as substantially equivalent to K010685 (Zimmer, Inc., 2001) and 2 other predicates after a 318-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- May 22, 2003
- Review
- 318 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K881779 (1988). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK881779 Whiteside Ortholoc II Unicondylar Knee SystemDow Corning Wright · 1988
- 1 generation backK014171 Advance Unicondylar Knee SystemWrightmedicaltechnologyinc · 2002
- This deviceK022211 HLS Uni Evolution ProsthesisTornier · 2003
- Descendant · cites it directly · 0 of its ownK120262 HLS Uni Evolution & U-KneetecTornier, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120262HLS Uni Evolution & U-KneetecTornier, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881779 | Whiteside Ortholoc II Unicondylar Knee System | Dow Corning Wright | 1988 | — |
| −1 | K014171 | Advance Unicondylar Knee System | Wrightmedicaltechnologyinc | 2002 | — |
| 0 (this device) | K022211 | HLS Uni Evolution Prosthesis | Tornier | 2003 | — |
| +1 | K120262 | HLS Uni Evolution & U-Kneetec | Tornier, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K010685 | Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM Articular… | 2001 |
| * | K014171 | Advance Unicondylar Knee System | 2002 |
| * | K954186 | Sled Unicompartment Knee SystemSummary page 1…coat Unicompartmental, Zimmer, Inc; KO 10685 Advance Unicondylar Knee System, Wright Medical Technology, Inc; KO 14 171 Link Endo-Model Sled Uni-Knee, Link America, Inc; K954186 Tornier S A . VI1 - 1… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120262 | HLS Uni Evolution & U-Kneetec | 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 13.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K120262 (Tornier, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K010685.
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 HLS Uni Evolution prosthesis is intended for the replacement of the medial or lateral compartment of the femoro-tibial knee joint, when only one side of the knee is affected. This device is indicated in case of primary or secondary femoro-tibial arthritis.
The HLS Uni Evolution prosthesis is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022211: HLS Uni Evolution Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022211
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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