510(k) · Cleared
Recalled · Class II · 2020Vanguard M Series Unicondylar Tibial Bearings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Nov 1, 2004 as substantially equivalent to K021621 (Biomet, Inc., 2002) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 1, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- HRY
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K971938 (1997). 3 ancestors in all, the oldest K954186 (1996). 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
- 1 generation backK021621 Fixed Bearing Uni ComponentBiomet, Inc. · 2002
- This deviceK042093 Vanguard M Series Unicondylar Tibial BearingsBiomet, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK122277 Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial…Biomet Manufacturing Corp · 2012 · Recalled
- Descendant · cites it directly · 2 of its ownK050764 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 · 1 of its ownK133940 Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings /…Biomet UK, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK260796 Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122277Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford…Biomet Manufacturing Corp · 2012 · cites it directly2descendants
- K050764Uniglide Unicondylar Knee ProsthesisCorin USA · 2005 · cites it directly2descendants
- K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. · 2017 · cites it directly1descendant
- K133940Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd. · 2014 · 2 generations on1descendant
- K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 2026 · 2 generations on0descendants
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 | K021621 | Fixed Bearing Uni Component | Biomet, Inc. | 2002 | — |
| 0 (this device) | K042093 | Vanguard M Series Unicondylar Tibial Bearings | Biomet, Inc. | 2004 | — |
| +1 | K122277 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays… | Biomet Manufacturing Corp | 2012 | 30 |
| +1 | K050764 | Uniglide Unicondylar Knee Prosthesis | Corin USA | 2005 | — |
| +1 | K170344 | Tahoe Uni Knee System | Consensus Orthopedics, Inc. | 2017 | — |
| +2 | K133940 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays) | Biomet UK, Ltd. | 2014 | 4 |
| +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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K021621 | Fixed Bearing Uni ComponentSummary page 1…fication Name: Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer (21 CER 888.3530) Substantially Equivalent Devices: Fixed Bearing Uni Component (K021621); Repicci IITM T Unicondylar Knee (K(971938); The Link® Endo-Model" Sled Uni-Kn… | 2002 |
| * | K971938 | Repicci II Unicondylar KneeSummary page 1…R 888.3530) Substantially Equivalent Devices: Fixed Bearing Uni Component (K021621); Repicci IITM T Unicondylar Knee (K(971938); The Link® Endo-Model" Sled Uni-Knee (K(954186). Device Description: The tibial component consists of ArCom®, ultrahigh molecula… | 1997 |
| * | K954186 | Sled Unicompartment Knee SystemSummary page 1…xed Bearing Uni Component (K021621); Repicci IITM T Unicondylar Knee (K(971938); The Link® Endo-Model" Sled Uni-Knee (K(954186). Device Description: The tibial component consists of ArCom®, ultrahigh molecular weight polyethylene (UHMWPE) plateau molded ov… | 1996 |
What descends from it? (6)
3 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 |
|---|---|---|---|---|
| Apr 17, 2020 | Class II | Z-2155-2020 | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit |
| Apr 22, 2015 | Class II | Z-1798-2015 | Process control | The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K122277 (Biomet Manufacturing Corp, 2012) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K021621.
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?
Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
This device is intended to be used with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042093: Vanguard M Series Unicondylar Tibial Bearings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042093
Report an extraction error
Are you the manufacturer?
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