510(k) Report

510(k) · Cleared

Cleared

Unicompartmental Knee

K072704510(k) TraditionalCleared Feb 19, 2008148-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

Valpo Orthopedic Technology, Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Feb 19, 2008 as substantially equivalent to K971938 (Biomet, Inc., 1997) and 5 other predicates after a 148-day review. Its family tree reaches back 2 generations to 1997.

Decided
Feb 19, 2008
Review
148 days
Class
Class II
Product code
HRY
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K971938 (1997). 11 ancestors in all, the oldest K880155 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2004: 2 other ancestors2001: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor1993: 1 other ancestor1988: 1 other ancestorK971938 · Repicci II Unicondylar Knee · Biomet, Inc. · 1997 · recalledK020264 · Repicci II Unicondylar Knee System · Biomet Orthopedics, Inc. · 2002198519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 5 other ancestors K020264 · Repicci II Unicondylar Knee System · Biomet Orthopedics, Inc. · 2002K971938 · Repicci II Unicondylar Knee · Biomet, Inc. · 1997 · recalled0
  1. Root · 2 generations backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
  2. 1 generation backK020264 Repicci II Unicondylar Knee SystemBiomet Orthopedics, Inc. · 2002
  3. This deviceK072704 Unicompartmental KneeValpo Orthopedic Technology, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K971938Repicci II Unicondylar KneeBiomet, Inc.19971
−1K020264Repicci II Unicondylar Knee SystemBiomet Orthopedics, Inc.2002—
0 (this device)K072704Unicompartmental KneeValpo Orthopedic Technology, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199310
199610
199810
199910
200110
200420
200610
FIG. 1 — Lineage of K072704, 1997–2008Source: 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? (6)

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
…Prosthesis (21 CFR 888.3530) 6. Legally Marketed Devices to which Substantial Equivalence is Claimed: a. Repicci II Unicompartmental Knee. (K971938) b. Zimmer Unicompartmental Knee System (K033363) c. Miller /Galante Precoat Unicompartmental Knee (I<010…
Biomet, Inc.19971
*K033363Zimmer Unicompartmental Knee System
Summary page 1
…keted Devices to which Substantial Equivalence is Claimed: a. Repicci II Unicompartmental Knee. (K971938) b. Zimmer Unicompartmental Knee System (K033363) c. Miller /Galante Precoat Unicompartmental Knee (I<010685) d. EIUS Unicompartmental Knee System -(K0337…
Zimmer, Inc.20043
*K010685Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM Articular…
Summary page 1
…Repicci II Unicompartmental Knee. (K971938) b. Zimmer Unicompartmental Knee System (K033363) c. Miller /Galante Precoat Unicompartmental Knee (I<010685) d. EIUS Unicompartmental Knee System -(K033769) e. Active Unicompartmental Knee System (K060412)…
Zimmer, Inc.2001—
*K033769Eius Unicompartmental Knee System
Summary page 1
…Zimmer Unicompartmental Knee System (K033363) c. Miller /Galante Precoat Unicompartmental Knee (I<010685) d. EIUS Unicompartmental Knee System -(K033769) e. Active Unicompartmental Knee System (K060412) f. Repicci II Unicondylar Knee System-(l(020264)…
Howmedica Osteonics Corp.2004—
*K060412Active Unicompartmental Knee System
Summary page 1
…/Galante Precoat Unicompartmental Knee (I<010685) d. EIUS Unicompartmental Knee System -(K033769) e. Active Unicompartmental Knee System (K060412) f. Repicci II Unicondylar Knee System-(l(020264) 7. Device Description: The VOT Uni Knee consists of a f…
Australian Surgical Design & Manufacture2006—
*K020264Repicci II Unicondylar Knee System
Summary page 1
…EIUS Unicompartmental Knee System -(K033769) e. Active Unicompartmental Knee System (K060412) f. Repicci II Unicondylar Knee System-(l(020264) 7. Device Description: The VOT Uni Knee consists of a femoral and a tibial component. The low profiled prosth…
Biomet Orthopedics, Inc.2002—

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?

  • The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
  • 5 of the 11 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. 2008, this device’s year, is highlighted.

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 Unicompartmental Knee is indicated for:

The Unicompartmental Knee is solely indicated for medial compartment replacement of the articulating surface 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 procedures. This device is intended for cemented use 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
  • 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
  • K060412Active Unicompartmental Knee SystemAustralian Surgical Design & Manufacture · 2006

More from Valpo Orthopedic Technology, Inc.

2 FDA decisions under this applicant name. See the company

  • K062734Adjust-Right Fixation DevicesValpo Orthopedic Technology, Inc. · 2006

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/K072704 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072704: Unicompartmental Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072704

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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