510(k) Report

510(k) · Cleared

Cleared

Fixed Bearing Uni Component

K021621510(k) SpecialCleared Jun 5, 200220-day reviewClass II21 CFR 888.3530

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet, Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Jun 5, 2002 as substantially equivalent to K971938 (Biomet, Inc., 1997) after a 20-day review. Its family tree reaches back 1 generation to 1997. 7 later devices descend from it.

Decided
Jun 5, 2002
Review
20 days
Class
Class II
Product code
HRY
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K971938 (1997). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2017: 1 descendant cleared2012: 1 descendant cleared2005: 1 descendant cleared2026: 1 descendant cleared2014: 1 descendant cleared2025: 1 descendant clearedK971938 · Repicci II Unicondylar Knee · Biomet, Inc. · 1997 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K971938 · Repicci II Unicondylar Knee · Biomet, Inc. · 1997 · recalled0
  1. Root · 1 generation backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
  2. This deviceK021621 Fixed Bearing Uni ComponentBiomet, Inc. · 2002
  3. Descendant · cites it directly · 6 of its ownK042093 Vanguard M Series Unicondylar Tibial BearingsBiomet, Inc. · 2004 · Recalled
  4. Descendant · 2 generations on · 2 of its ownK122277 Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial…Biomet Manufacturing Corp · 2012 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK050764 Uniglide Unicondylar Knee ProsthesisCorin USA · 2005
  6. Descendant · cites it directly · 1 of its ownK170344 Tahoe Uni Knee SystemConsensus Orthopedics, Inc. · 2017
  7. Descendant · 3 generations on · 1 of its ownK133940 Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings /…Biomet UK, Ltd. · 2014 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12012: 12014: 12017: 12025: 12026: 1
2004high 1 (2004) · low 0 (2006)2026

Most influential descendants

Showing 5 of 7 · See all
  • K042093Vanguard M Series Unicondylar Tibial BearingsBiomet, Inc. · 2004 · cites it directly6descendants
  • K122277Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford…Biomet Manufacturing Corp · 2012 · 2 generations on2descendants
  • K050764Uniglide Unicondylar Knee ProsthesisCorin USA · 2005 · 2 generations on2descendants
  • K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. · 2017 · cites it directly1descendant
  • K133940Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd. · 2014 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971938Repicci II Unicondylar KneeBiomet, Inc.19971
0 (this device)K021621Fixed Bearing Uni ComponentBiomet, Inc.2002—
+1K042093Vanguard M Series Unicondylar Tibial BearingsBiomet, Inc.20042
+2K122277Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays…Biomet Manufacturing Corp201230
+2K050764Uniglide Unicondylar Knee ProsthesisCorin USA2005—
+1K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.2017—
+3K133940Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd.20144

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
201210
201410
201710
202510
202610
FIG. 1 — Lineage of K021621, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K971938Repicci II Unicondylar Knee
Summary page 1
…ed, metaVpolymer (21 CFR 888.3530) Device Classification: Class I1 Legally Marketed Device to which Substantially Equivalence is Claimed: Repicci IITMUnicondylar Knee (K97 1938) Device Description: The tibial component consists of polyethylene plateau molded over a one-piece Co-Cr-Mo base and central kee…
Biomet, Inc.19971

Also cleared against K971938: 13 other devices →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042093Vanguard M Series Unicondylar Tibial BearingsBiomet, Inc.20046
K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.20171

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?

  • Its one ancestor has a recall.
  • Of its descendants, K042093 (Biomet, Inc., 2004) has gone furthest, with 6 descendants of its own.
  • 13 other devices also cite its predicate K971938.

How does its category compare?

All HRY devices

HRY 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

2007: 32008: 32010: 12011: 12012: 12013: 12014: 12015: 12016: 12019: 12020: 1
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRY

138in 2008

2007: 92 days median2008: 138 days median
2007high 138 (2008) · low 92 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRY

3in 2022

2007: 12008: 12011: 12013: 12016: 12020: 12021: 12022: 3
2007high 3 (2022) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRY

290in 2025

2007: 2632008: 2852009: 2492010: 1802011: 1552012: 1372013: 3832014: 3052015: 3452016: 3432017: 4022018: 6132019: 3672020: 1,0542021: 1,2182022: 8402023: 3962024: 4302025: 290
2007high 1,218 (2021) · low 137 (2012)2025

MAUDE reports naming product code HRY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073921263
200831381285
20090—0249
20101—0180
20111—1155
20121—0137
20131—1383
20141—0305
20151—0345
20161—1343
20170—0402
20180—0613
20191—0367
20201—11,054
20210—11,218
20220—3840
20230—0396
20240—0430
20250—0290
20260—0—

What is it indicated for?

The Fixed Bearing Uni Component is indicated for use for 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; 2) Correction of varus, valgus, or posttraumatic deformity; and 3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is intended to be used with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K971938

13 other devices cite the same predicate.

  • K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. · 2017
  • K161592Persona Partial Knee SystemBiomet, Inc. · 20162 recalls
  • K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
  • K072704Unicompartmental KneeValpo Orthopedic Technology, Inc. · 2008
  • K063515Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar KneeBiomet Manufacturing, Inc. · 2007
  • K061681Repicci II Metal Back Inlay Unicompartmental Tibial Bearing ComponentBiomet Manufacturing Corp · 2006

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in HRY

The HRY category page

  • K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC · 2020
  • K190633NanoOrtho NanoKnee® SystemNanoortho, LLC · 2019
  • K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc. · 2016
  • K150410Restoris Porous Partial Knee SystemMako Surgical Corporation · 2015
  • K133940Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd. · 20144 recalls

https://510kreport.com/device/K021621 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021621: Fixed Bearing Uni Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021621

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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