510(k) Report

510(k) · Cleared

Recalled · 2007

Unicondylar Knee

K020741510(k) TraditionalCleared Jun 4, 200290-day reviewClass II21 CFR 888.3530Recalls 2

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

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

Cleared on Jun 4, 2002 as substantially equivalent to K971938 (Biomet, Inc., 1997) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1997. 81 later devices descend from it. It has been recalled 2 times.

Decided
Jun 4, 2002
Review
90 days
Class
Class II
Product code
HRY
Recalls
2
Predicates
4

Its longest line of descent runs back 1 generation to K971938 (1997). 4 ancestors in all. 81 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1998: 1 other ancestor2008: 4 descendants cleared2017: 4 descendants cleared2002: 1 descendant cleared2007: 1 descendant cleared2013: 3 descendants cleared2026: 7 descendants cleared2009: 2 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared2014: 2 descendants cleared2016: 1 descendant cleared2024: 5 descendants cleared2015: 2 descendants cleared2019: 7 descendants cleared2021: 10 descendants cleared2020: 9 descendants cleared2025: 5 descendants cleared2023: 9 descendants cleared2018: 2 descendants cleared2022: 5 descendants clearedK971938 · Repicci II Unicondylar Knee · Biomet, Inc. · 1997 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 7 descendants4 generations forward: 13 descendants5 generations forward: 24 descendants6 generations forward: 13 descendants7 generations forward: 6 descendants8 generations forward: 2 descendants9 generations forward: 3 descendants10 generations forward: 3 descendants11 generations forward: 2 descendants K971938 · Repicci II Unicondylar Knee · Biomet, Inc. · 1997 · recalled0+5+10
  1. Root · 1 generation backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
  2. This deviceK020741 Unicondylar KneeEncore Orthopedics, Inc. · 2002
  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
  7. Descendant · 2 generations on · 31 of its ownK072368 Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · Recalled

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

2002: 12007: 12008: 42009: 22011: 12012: 12013: 32014: 22015: 22016: 12017: 42018: 22019: 72020: 92021: 102022: 52023: 92024: 52025: 52026: 7
2002high 10 (2021) · low 0 (2003)2026

Most influential descendants

Showing 5 of 81 · See all
  • 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
  • K072368Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · 2 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971938Repicci II Unicondylar KneeBiomet, Inc.19971
0 (this device)K020741Unicondylar KneeEncore Orthopedics, Inc.2002—
+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
+2K072368Conformis Metal Backed Tibial ComponentConformis, Inc.20073

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200710
200840
200920
201110
201210
201330
201420
201520
201610
201740
201820
201970
202090
2021100
202250
202390
202450
202550
202670
FIG. 1 — Lineage of K020741, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K971938Repicci II Unicondylar Knee
Summary page 1
…Knee Common or usual name: Knee system Classification name: Class I1 (3) Predicate devices: Biomet Repicci I1 (K971938, K980665) DePuy Preservation (K010810) Wr…
Biomet, Inc.19971
*K980665Repicci II Unicondylar Knee All Poly Tibial Components
Summary page 1
…Common or usual name: Knee system Classification name: Class I1 (3) Predicate devices: Biomet Repicci I1 (K971938, K980665) DePuy Preservation (K010810) Wright Adva…
Biomet, Inc.19981
*K010810Depuy Preservation Unicondylar Knee Prosthesis
Summary page 1
…: Class I1 (3) Predicate devices: Biomet Repicci I1 (K971938, K980665) DePuy Preservation (K010810) Wright Advance (K012591) (4) Subject device description: The Uni Knee is c…
DePuy Orthopaedics, Inc.200119
*K012591Advance Unicondylar Knee System
Summary page 1
…Biomet Repicci I1 (K971938, K980665) DePuy Preservation (K010810) Wright Advance (K012591) (4) Subject device description: The Uni Knee is comprised of a femoral and a tibial component. The femoral compo…
Wrightmedicaltechnologyinc2001—

Also cleared against K971938: 13 other devices →

What descends from it? (81)

See all 81

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

NumberDeviceApplicantDecidedDescendants
K022437Uni KneeEncore Medical L.P.200280
K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.200856
K082081Mako Surgical Corporation Unicondylar Knee Implant System IiiMako Surgical Corp.200812
K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.20171

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 9, 2007Not classifiedZ-0009-2008Device DesignAngled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.
Aug 9, 2007Not classifiedZ-0010-2008Device DesignAngled 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?

  • 3 of the 4 ancestors have a recall of any class.
  • Of its descendants, K022437 (Encore Medical L.P., 2002) has gone furthest, with 80 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?

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.

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 Encore Orthopedics, Inc.

85 FDA decisions under this applicant name. See the company

  • K0329053DKNEE Porous Coated Femoral ComponentEncore Orthopedics, Inc. · 2004
  • K0201143D KNEEEncore Orthopedics, Inc. · 20025 recalls
  • K020236Modification to Pass Spinal SystemEncore Orthopedics, Inc. · 2002
  • K020170Keystone Hip System Calcar Replacement Body and Build UPEncore Orthopedics, Inc. · 2002
  • K013490Cemented Calcar Hip SystemEncore Orthopedics, Inc. · 2002

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/K020741 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020741: 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/K020741

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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