510(k) · Cleared
Recalled · 2007Uni Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Aug 23, 2002 as substantially equivalent to K020741 (Encore Orthopedics, Inc., 2002) and 4 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1997. 80 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 23, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- HRY
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 2 generations to K971938 (1997). 5 ancestors in all. 80 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
- 1 generation backK020741 Unicondylar KneeEncore Orthopedics, Inc. · 2002 · Recalled
- This deviceK022437 Uni KneeEncore Medical L.P. · 2002
- Descendant · cites it directly · 56 of its ownK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
- Descendant · 2 generations on · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- Descendant · 3 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- Descendant · cites it directly · 31 of its ownK072368 Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 29 of its ownK092441 Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008 · cites it directly56descendants
- K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · 2 generations on51descendants
- K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · 3 generations on50descendants
- K072368Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · cites it directly31descendants
- K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009 · 2 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971938 | Repicci II Unicondylar Knee | Biomet, Inc. | 1997 | 1 |
| −1 | K020741 | Unicondylar Knee | Encore Orthopedics, Inc. | 2002 | 2 |
| 0 (this device) | K022437 | Uni Knee | Encore Medical L.P. | 2002 | — |
| +1 | K080368 | Mako Surgical Corp. Unicondylar Knee Implant System II | Mako Surgical Corp. | 2008 | — |
| +2 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| +3 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| +1 | K072368 | Conformis Metal Backed Tibial Component | Conformis, Inc. | 2007 | 3 |
| +2 | K092441 | Modification to: Conformis Iuni Unicondylar Knee Repair System | Conformis, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 9 | 0 |
| 2021 | 10 | 0 |
| 2022 | 5 | 0 |
| 2023 | 9 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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? (5)
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 |
|---|---|---|---|
| * | K020741 | Unicondylar KneeSummary page 1…on or usual name: Knee system Classification name: Class I1 Predicate devices: Encore Uni Knee (K020741) Biomet Repicci II (K971938, K980665)… | 2002 |
| * | K971938 | Repicci II Unicondylar KneeSummary page 1…Class I1 Predicate devices: Encore Uni Knee (K020741) Biomet Repicci II (K971938, K980665) DePuy Preservation (KO10810)… | 1997 |
| * | K980665 | Repicci II Unicondylar Knee All Poly Tibial ComponentsSummary page 1…Class I1 Predicate devices: Encore Uni Knee (K020741) Biomet Repicci II (K971938, K980665) DePuy Preservation (KO10810) Wrigh… | 1998 |
| * | K010810 | Depuy Preservation Unicondylar Knee Prosthesis | 2001 |
| * | K012591 | Advance Unicondylar Knee SystemSummary page 1…Repicci II (K971938, K980665) DePuy Preservation (KO10810) Wright Advance (K012591) Subject device description: The additional components that are the subject of this Special 510(k) submission are the tib… | 2001 |
What descends from it? (80)
See all 804 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2007 | Not classified | Z-0009-2008 | Device Design | Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site. |
| Aug 9, 2007 | Not classified | Z-0010-2008 | Device Design | Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K080368 (Mako Surgical Corp., 2008) has gone furthest, with 56 descendants of its own.
- 3 other devices also cite its predicate K020741.
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?
Intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022437: Uni Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022437
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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