510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Repicci II Unicondylar Knee All Poly Tibial Components

K980665510(k) TraditionalCleared May 20, 199889-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 May 20, 1998 after an 89-day review. The FDA summary names no predicate by number. 129 later devices descend from it. It has been recalled once.

Decided
May 20, 1998
Review
89 days
Class
Class II
Product code
HRY
Recalls
1
Predicates
0

129 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2006: 6 descendants cleared2001: 1 descendant cleared2005: 3 descendants cleared2004: 1 descendant cleared2003: 1 descendant cleared2008: 5 descendants cleared2017: 4 descendants cleared2007: 5 descendants cleared2009: 3 descendants cleared2011: 3 descendants cleared2012: 7 descendants cleared2023: 10 descendants cleared2016: 7 descendants cleared2020: 9 descendants cleared2024: 6 descendants cleared2018: 3 descendants cleared2013: 7 descendants cleared2026: 7 descendants cleared2010: 1 descendant cleared2014: 7 descendants cleared2019: 8 descendants cleared2021: 10 descendants cleared2025: 5 descendants cleared2022: 5 descendants cleared2015: 3 descendants cleared1995200020052010201520202025
  1. This deviceK980665 Repicci II Unicondylar Knee All Poly Tibial ComponentsBiomet, Inc. · 1998
  2. Descendant · cites it directly · 121 of its ownK033769 Eius Unicompartmental Knee SystemHowmedica Osteonics Corp. · 2004
  3. Descendant · cites it directly · 81 of its ownK020741 Unicondylar KneeEncore Orthopedics, Inc. · 2002 · Recalled
  4. Descendant · cites it directly · 80 of its ownK022437 Uni KneeEncore Medical L.P. · 2002 · Recalled
  5. Descendant · 2 generations on · 62 of its ownK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
  6. Descendant · 2 generations on · 56 of its ownK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008

Showing 5 of 129 descendants. See all descendants

Descendants cleared per year

2001: 12002: 22003: 12004: 12005: 32006: 62007: 52008: 52009: 32010: 12011: 32012: 72013: 72014: 72015: 32016: 72017: 42018: 32019: 82020: 92021: 102022: 52023: 102024: 62025: 52026: 7
2001high 10 (2021) · low 1 (2001)2026

Most influential descendants

Showing 5 of 129 · See all
  • K033769Eius Unicompartmental Knee SystemHowmedica Osteonics Corp. · 2004 · cites it directly121descendants
  • K020741Unicondylar KneeEncore Orthopedics, Inc. · 2002 · cites it directly81descendants
  • K022437Uni KneeEncore Medical L.P. · 2002 · cites it directly80descendants
  • K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · 2 generations on62descendants
  • K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008 · 2 generations on56descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K980665Repicci II Unicondylar Knee All Poly Tibial ComponentsBiomet, Inc.1998—
+1K033769Eius Unicompartmental Knee SystemHowmedica Osteonics Corp.2004—
+1K020741Unicondylar KneeEncore Orthopedics, Inc.20022
+1K022437Uni KneeEncore Medical L.P.20022
+2K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc.20053
+2K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200220
200310
200410
200530
200660
200750
200850
200930
201010
201130
201270
201370
201470
201530
201670
201740
201830
201980
202090
2021100
202250
2023100
202460
202550
202670
FIG. 1 — Lineage of K980665, 1998–2026Source: 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? (129)

See all 129

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

NumberDeviceApplicantDecidedDescendants
K033769Eius Unicompartmental Knee SystemHowmedica Osteonics Corp.2004121
K020741Unicondylar KneeEncore Orthopedics, Inc.200281
K022437Uni KneeEncore Medical L.P.200280
K050764Uniglide Unicondylar Knee ProsthesisCorin USA20052
K011795Worland Unicondylar Tibial BearingBiomet, Inc.20011
K061681Repicci II Metal Back Inlay Unicompartmental Tibial Bearing ComponentBiomet Manufacturing Corp20060
K053299Repicci II Onlay Unicompartmental Tibial ComponentBiomet Manufacturing, Inc.20060

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, K033769 (Howmedica Osteonics Corp., 2004) has gone furthest, with 121 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 devices covered by this 510 (k) are intended to be used with a Repicci Femoral component.

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/K980665 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980665: Repicci II Unicondylar Knee All Poly Tibial Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980665

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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