510(k) · Cleared
ClearedAdvance Unicondylar Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Mar 15, 2002 as substantially equivalent to K012591 (Wrightmedicaltechnologyinc, 2001) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1988. 3 later devices descend from it.
- Decided
- Mar 15, 2002
- Review
- 85 days
- Class
- Class II
- Product code
- HRY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K881779 (1988). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK881779 Whiteside Ortholoc II Unicondylar Knee SystemDow Corning Wright · 1988
- This deviceK014171 Advance Unicondylar Knee SystemWrightmedicaltechnologyinc · 2002
- Descendant · cites it directly · 1 of its ownK022211 HLS Uni Evolution ProsthesisTornier · 2003
- Descendant · 2 generations on · 0 of its ownK120262 HLS Uni Evolution & U-KneetecTornier, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK100973 Evolution Unicondylar Knee SystemWrightmedicaltechnologyinc · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881779 | Whiteside Ortholoc II Unicondylar Knee System | Dow Corning Wright | 1988 | — |
| 0 (this device) | K014171 | Advance Unicondylar Knee System | Wrightmedicaltechnologyinc | 2002 | — |
| +1 | K022211 | HLS Uni Evolution Prosthesis | Tornier | 2003 | — |
| +2 | K120262 | HLS Uni Evolution & U-Kneetec | Tornier, Inc. | 2012 | — |
| +1 | K100973 | Evolution Unicondylar Knee System | Wrightmedicaltechnologyinc | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 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 HRY? 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 HRY device
- #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K012591 | Advance Unicondylar Knee SystemSummary page 2…DESCRIPTION The ADVANCE® Unicondylar modular metal-backed tibia is part of the ADVANCE® Unicondylar Knee System that was previously submitted and cleared under 510(k): K012591- ADVANCE® Unicondylar Knee System. Wright Medical Technology is now enhancing the ADVANCE® Unicondylar Knee System by adding a mo… | 2001 |
| * | K881779 | Whiteside Ortholoc II Unicondylar Knee SystemSummary page 2…‘ADVANCE® Unicondylar modular metal-backed tibial components is substantially equivalent to the ADVANT IM® Unicondylar modular metal- ~ backed tibial components (510(k): K881779). Table 1 is a comparison chart summarizing the above design features for the ADVANCE® Unicondylar modular metal- backed tibial… | 1988 |
What descends from it? (3)
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?
How does its category compare?
All HRY devicesHRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HRY
138in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRY
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRY
290in 2025
MAUDE reports naming product code HRY, 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 | 3 | 92 | 1 | 263 |
| 2008 | 3 | 138 | 1 | 285 |
| 2009 | 0 | — | 0 | 249 |
| 2010 | 1 | — | 0 | 180 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 1 | — | 0 | 137 |
| 2013 | 1 | — | 1 | 383 |
| 2014 | 1 | — | 0 | 305 |
| 2015 | 1 | — | 0 | 345 |
| 2016 | 1 | — | 1 | 343 |
| 2017 | 0 | — | 0 | 402 |
| 2018 | 0 | — | 0 | 613 |
| 2019 | 1 | — | 0 | 367 |
| 2020 | 1 | — | 1 | 1,054 |
| 2021 | 0 | — | 1 | 1,218 |
| 2022 | 0 | — | 3 | 840 |
| 2023 | 0 | — | 0 | 396 |
| 2024 | 0 | — | 0 | 430 |
| 2025 | 0 | — | 0 | 290 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have…
Read the full statement (121 words)
Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2) inflammatory degenerative joint disease including rheumatoid arthritis;
3) correction of functional deformity;
4) revision procedures where other treatments or devices have failed; and
5) treatment of fractures that are unmanageable using other techniques.
Unicondylar knee system is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
The ADVANCE® Unicondylar Knee System components are for single use only.
The ADVANCE® Unicondylar Knee System components are for cemented use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014171: Advance Unicondylar Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014171
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026