510(k) · Cleared
ClearedUniglide Unicondylar Knee Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Aug 24, 2005 as substantially equivalent to K042093 (Biomet, Inc., 2004) and 3 other predicates after a 153-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.
- Decided
- Aug 24, 2005
- Review
- 153 days
- Class
- Class II
- Product code
- HRY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K971938 (1997). 7 ancestors in all, the oldest K954186 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
- 2 generations backK021621 Fixed Bearing Uni ComponentBiomet, Inc. · 2002
- 1 generation backK042093 Vanguard M Series Unicondylar Tibial BearingsBiomet, Inc. · 2004 · Recalled
- This deviceK050764 Uniglide Unicondylar Knee ProsthesisCorin USA · 2005
- Descendant · cites it directly · 1 of its ownK170344 Tahoe Uni Knee SystemConsensus Orthopedics, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK260796 Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971938 | Repicci II Unicondylar Knee | Biomet, Inc. | 1997 | 1 |
| −2 | K021621 | Fixed Bearing Uni Component | Biomet, Inc. | 2002 | — |
| −1 | K042093 | Vanguard M Series Unicondylar Tibial Bearings | Biomet, Inc. | 2004 | 2 |
| 0 (this device) | K050764 | Uniglide Unicondylar Knee Prosthesis | Corin USA | 2005 | — |
| +1 | K170344 | Tahoe Uni Knee System | Consensus Orthopedics, Inc. | 2017 | — |
| +2 | K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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 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? (4)
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 |
|---|---|---|---|
| * | K042093 | Vanguard M Series Unicondylar Tibial BearingsSummary page 2…Page 4 Substantially Equivalent Devices: Vanguard MTM Series Unicondylar Tibial Bearings (K042093); Repicci I1TM Unicondylar Knee (K980665); Link Endo-ModelT' Sled Uni- knee (K954186); UC Plus Solution Unicondylar Knee System (… | 2004 |
| * | K980665 | Repicci II Unicondylar Knee All Poly Tibial ComponentsSummary page 2…Page 4 Substantially Equivalent Devices: Vanguard MTM Series Unicondylar Tibial Bearings (K042093); Repicci I1TM Unicondylar Knee (K980665); Link Endo-ModelT' Sled Uni- knee (K954186); UC Plus Solution Unicondylar Knee System (K982859) Device Description: The device… | 1998 |
| * | K954186 | Sled Unicompartment Knee SystemSummary page 2…= Substantially Equivalent Devices: Vanguard MTM Series Unicondylar Tibial Bearings (K042093); Repicci I1TM Unicondylar Knee (K980665); Link Endo-ModelT' Sled Uni- knee (K954186); UC Plus Solution Unicondylar Knee System (K982859) Device Description: The device consists of Cobalt Chrome (CoCr) alloy femo… | 1996 |
| * | K982859 | UC-Plus Solution Unicondylar Knee SystemSummary page 2…ies Unicondylar Tibial Bearings (K042093); Repicci I1TM Unicondylar Knee (K980665); Link Endo-ModelT' Sled Uni- knee (K954186); UC Plus Solution Unicondylar Knee System (K982859) Device Description: The device consists of Cobalt Chrome (CoCr) alloy femoral component which articulates against an ultra hig… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170344 | Tahoe Uni Knee System | 2017 | 1 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K170344 (Consensus Orthopedics, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K042093.
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?
The Uniglide unicondylar knee replacement system is indicated for use in the replacement of the articulating surfaces of one tibio-femoral compartment of the knee where this has been affected by primary degenerative disease, post traumatic degenerative disease or damage due to previous surgical intervention. The device is indicated in these cases where the degeneration is substantially limited to the compartment to be replaced and the anterior and…
Read the full statement (108 words)
The Uniglide unicondylar knee replacement system is indicated for use in the replacement of the articulating surfaces of one tibio-femoral compartment of the knee where this has been affected by primary degenerative disease, post traumatic degenerative disease or damage due to previous surgical intervention. The device is indicated in these cases where the degeneration is substantially limited to the compartment to be replaced and the anterior and posterior cruciate ligaments are present and functionally intact. The device is indicated for use in the medial or lateral compartment of the knee. The device is intended to be used with bone cement. The device is intended for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050764: Uniglide Unicondylar Knee Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050764
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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