510(k) Report

510(k) · Cleared

Cleared

Repicci II Onlay Unicompartmental Tibial Component

K053299510(k) TraditionalCleared Jan 5, 200641-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 Manufacturing, Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Jan 5, 2006 as substantially equivalent to K971938 (Biomet, Inc., 1997) and 3 other predicates after a 41-day review. Its family tree reaches back 1 generation to 1997.

Decided
Jan 5, 2006
Review
41 days
Class
Class II
Product code
HRY
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K971938 (1997). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 2 other ancestors1998: 1 other ancestorK971938 · Repicci II Unicondylar Knee · Biomet, Inc. · 1997 · recalled1996199820002002200420062008
Other ancestors, by generation 1 generation back: 3 other ancestors K971938 · Repicci II Unicondylar Knee · Biomet, Inc. · 1997 · recalled0
  1. Root · 1 generation backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
  2. This deviceK053299 Repicci II Onlay Unicompartmental Tibial ComponentBiomet Manufacturing, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971938Repicci II Unicondylar KneeBiomet, Inc.19971
0 (this device)K053299Repicci II Onlay Unicompartmental Tibial ComponentBiomet Manufacturing, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200120
FIG. 1 — Lineage of K053299, 1997–2006Source: 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
…strained cemented prosthesis (21 GREF 888.3530, 87 HRY) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: *Repicci IIl) Unicondylar Knee (Biomet-K971938, K980665) *DePuy Preservation"T Unicondylar Knee Prosthesis (DePuy Orthopedics, Inc. - K010810) *ADVANCE® Unicondylar…
Biomet, Inc.19971
*K980665Repicci II Unicondylar Knee All Poly Tibial Components
Summary page 1
…cemented prosthesis (21 GREF 888.3530, 87 HRY) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: *Repicci IIl) Unicondylar Knee (Biomet-K971938, K980665) *DePuy Preservation"T Unicondylar Knee Prosthesis (DePuy Orthopedics, Inc. - K010810) *ADVANCE® Unicondylar Knee Syst…
Biomet, Inc.19981
*K010810Depuy Preservation Unicondylar Knee Prosthesis
Summary page 1
…Equivalence Is Claimed: *Repicci IIl) Unicondylar Knee (Biomet-K971938, K980665) *DePuy Preservation"T Unicondylar Knee Prosthesis (DePuy Orthopedics, Inc. - K010810) *ADVANCE® Unicondylar Knee System (Wright Medical Technology, Inc.-K012591) Device Description: The Repicci Il® Onlay Tibial…
DePuy Orthopaedics, Inc.200119
*K012591Advance Unicondylar Knee System
Summary page 1
…0665) *DePuy Preservation"T Unicondylar Knee Prosthesis (DePuy Orthopedics, Inc. - K010810) *ADVANCE® Unicondylar Knee System (Wright Medical Technology, Inc.-K012591) Device Description: The Repicci Il® Onlay Tibial Component is an all-polyethylene unicondylar tibial component with four inferi…
Wrightmedicaltechnologyinc2001—

Also cleared against K971938: 13 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • 3 of the 4 ancestors have a recall of any class.
  • 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?

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.

This device is intended for cemented application only.

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 Manufacturing, Inc.

32 FDA decisions under this applicant name. See the company

  • K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc. · 20131 recall
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
  • K080685Hiploc Compression Hip ScrewBiomet Manufacturing, Inc. · 20084 recalls
  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 20088 recalls

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/K053299 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053299: Repicci II Onlay Unicompartmental Tibial Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053299

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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