510(k) Report

510(k) · Cleared

Recalled · 2007

Depuy Preservation Unicondylar Knee Prosthesis

K010810510(k) SpecialCleared Apr 18, 200130-day reviewClass II21 CFR 888.3530Recalls 19

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

DePuy Orthopaedics, Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Apr 18, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 99 later devices descend from it. It has been recalled 19 times.

Decided
Apr 18, 2001
Review
30 days
Class
Class II
Product code
HRY
Recalls
19
Predicates
0

99 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2009: 4 descendants cleared2006: 2 descendants cleared2002: 2 descendants cleared2004: 3 descendants cleared2008: 4 descendants cleared2017: 4 descendants cleared2007: 4 descendants cleared2014: 2 descendants cleared2010: 1 descendant cleared2020: 10 descendants cleared2024: 7 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared2013: 3 descendants cleared2016: 2 descendants cleared2015: 2 descendants cleared2019: 9 descendants cleared2026: 7 descendants cleared2021: 10 descendants cleared2023: 9 descendants cleared2022: 5 descendants cleared2025: 5 descendants cleared2018: 2 descendants cleared200020052010201520202025
  1. This deviceK010810 Depuy Preservation Unicondylar Knee ProsthesisDePuy Orthopaedics, Inc. · 2001
  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 · 61 of its ownK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
  5. Descendant · 2 generations on · 59 of its ownK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
  6. Descendant · 2 generations on · 56 of its ownK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008

Showing 5 of 99 descendants. See all descendants

Descendants cleared per year

2002: 22004: 32006: 22007: 42008: 42009: 42010: 12011: 12012: 12013: 32014: 22015: 22016: 22017: 42018: 22019: 92020: 102021: 102022: 52023: 92024: 72025: 52026: 7
2002high 10 (2020) · low 0 (2003)2026

Most influential descendants

Showing 5 of 99 · See all
  • K020741Unicondylar KneeEncore Orthopedics, Inc. · 2002 · cites it directly81descendants
  • K022437Uni KneeEncore Medical L.P. · 2002 · cites it directly80descendants
  • K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · cites it directly61descendants
  • K070849Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007 · 2 generations on59descendants
  • 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)K010810Depuy Preservation Unicondylar Knee ProsthesisDePuy Orthopaedics, Inc.2001—
+1K020741Unicondylar KneeEncore Orthopedics, Inc.20022
+1K022437Uni KneeEncore Medical L.P.20022
+1K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc.20061
+2K070849Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc.2007—
+2K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200430
200620
200740
200840
200940
201010
201110
201210
201330
201420
201520
201620
201740
201820
201990
2020100
2021100
202250
202390
202470
202550
202670
FIG. 1 — Lineage of K010810, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (99)

See all 99

8 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
K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc.200661
K040268Depuy Preservation Unicondylar TibiaDePuy Orthopaedics, Inc.200447
K033810Natural-Knee II Unicompartmental Knee SystemCenterpulse Orthopedics, Inc.200420
K090024TGS Unicompartmental Knee Arthroplasty SystemAlexandria Research Technologies, LLC20091
K053299Repicci II Onlay Unicompartmental Tibial ComponentBiomet Manufacturing, Inc.20060
K040889Exactech Optetrak Unicondylar KneeExactech, Inc.20040

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 27, 2007Not classifiedZ-0433-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0430-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0428-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0429-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0431-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0432-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005Not classifiedZ-1152-05OtherAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005Not classifiedZ-1141-05OtherAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005Not classifiedZ-1151-05OtherAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005Not classifiedZ-1150-05OtherAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005Not classifiedZ-1153-05OtherAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005Not classifiedZ-1146-05OtherAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005Not classifiedZ-1147-05OtherAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005Not classifiedZ-1143-05OtherAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005Not classifiedZ-1142-05OtherAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005Not classifiedZ-1148-05OtherAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005Not classifiedZ-1145-05OtherAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005Not classifiedZ-1149-05OtherAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005Not classifiedZ-1144-05OtherAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

The 5 latest of 19 recalls; the web page lists all.

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—

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

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/K010810 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010810: Depuy Preservation Unicondylar Knee Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010810

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026