510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Repicci II Unicondylar Knee

K971938510(k) TraditionalCleared Aug 25, 199790-day reviewClass II21 CFR 888.3530Recalls 1

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 Aug 25, 1997 after a 90-day review. The FDA summary names no predicate by number. 101 later devices descend from it. It has been recalled once.

Decided
Aug 25, 1997
Review
90 days
Class
Class II
Product code
HRY
Recalls
1
Predicates
0

101 later devices descend from it, 14 citing it directly.

Descendants, by year cleared 2002: 4 descendants cleared2008: 5 descendants cleared2004: 1 descendant cleared2017: 4 descendants cleared2001: 1 descendant cleared2006: 3 descendants cleared2016: 2 descendants cleared2007: 2 descendants cleared2012: 2 descendants cleared2005: 1 descendant cleared2021: 10 descendants cleared2025: 8 descendants cleared2022: 6 descendants cleared2020: 10 descendants cleared2026: 8 descendants cleared2009: 2 descendants cleared2011: 1 descendant cleared2013: 3 descendants cleared2014: 3 descendants cleared2024: 5 descendants cleared2015: 2 descendants cleared2019: 7 descendants cleared2023: 9 descendants cleared2018: 2 descendants cleared1995200020052010201520202025
  1. This deviceK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997
  2. Descendant · cites it directly · 81 of its ownK020741 Unicondylar KneeEncore Orthopedics, Inc. · 2002 · Recalled
  3. Descendant · cites it directly · 80 of its ownK022437 Uni KneeEncore Medical L.P. · 2002 · Recalled
  4. Descendant · cites it directly · 56 of its ownK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
  5. Descendant · 2 generations on · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
  6. Descendant · 3 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled

Showing 5 of 101 descendants. See all descendants

Descendants cleared per year

2001: 12002: 42004: 12005: 12006: 32007: 22008: 52009: 22011: 12012: 22013: 32014: 32015: 22016: 22017: 42018: 22019: 72020: 102021: 102022: 62023: 92024: 52025: 82026: 8
2001high 10 (2020) · low 0 (2003)2026

Most influential descendants

Showing 5 of 101 · See all
  • K020741Unicondylar KneeEncore Orthopedics, Inc. · 2002 · cites it directly81descendants
  • K022437Uni KneeEncore Medical L.P. · 2002 · cites it directly80descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K971938Repicci II Unicondylar KneeBiomet, Inc.1997—
+1K020741Unicondylar KneeEncore Orthopedics, Inc.20022
+1K022437Uni KneeEncore Medical L.P.20022
+1K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.2008—
+2K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation20082
+3K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation20095

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200240
200410
200510
200630
200720
200850
200920
201110
201220
201330
201430
201520
201620
201740
201820
201970
2020100
2021100
202260
202390
202450
202580
202680
FIG. 1 — Lineage of K971938, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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?

The FDA summary names no predicate by number.

What descends from it? (101)

See all 101

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

NumberDeviceApplicantDecidedDescendants
K020741Unicondylar KneeEncore Orthopedics, Inc.200281
K022437Uni KneeEncore Medical L.P.200280
K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.200856
K021621Fixed Bearing Uni ComponentBiomet, Inc.20027
K042093Vanguard M Series Unicondylar Tibial BearingsBiomet, Inc.20046
K161592Persona Partial Knee SystemBiomet, Inc.20165
K020264Repicci II Unicondylar Knee SystemBiomet Orthopedics, Inc.20024
K011138Oxford Unicompartmental Knee Femoral ComponentBiomet, Inc.20013
K063515Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar KneeBiomet Manufacturing, Inc.20072
K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.20171

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 17, 2017Class IIZ-1863-2017Process designEndotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K020741 (Encore Orthopedics, Inc., 2002) has gone furthest, with 81 descendants of its own.

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?

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K971938 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971938: Repicci II Unicondylar Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971938

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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