510(k) Report

510(k) · Cleared

Recalled · 2006

Depuy Preservation Unicondylar Tibia

K040268510(k) SpecialCleared May 5, 200490-day reviewClass II21 CFR 888.3530Recalls 10

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 May 5, 2004 as substantially equivalent to K010810 (DePuy Orthopaedics, Inc., 2001) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1996. 47 later devices descend from it. It has been recalled 10 times.

Decided
May 5, 2004
Review
90 days
Class
Class II
Product code
HRY
Recalls
10
Predicates
2

Its longest line of descent runs back 1 generation to K954481 (1996). 2 ancestors in all. 47 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2007: 3 descendants cleared2010: 1 descendant cleared2009: 2 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared2020: 4 descendants cleared2024: 4 descendants cleared2008: 1 descendant cleared2016: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2019: 5 descendants cleared2021: 9 descendants cleared2023: 6 descendants cleared2022: 3 descendants cleared2026: 2 descendants cleared2025: 1 descendant clearedK954481 · P.F.C. Uni-Compartmental Knee System · Johnson & Johnson Professionals, Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 3 descendants4 generations forward: 4 descendants5 generations forward: 9 descendants6 generations forward: 9 descendants7 generations forward: 3 descendants8 generations forward: 3 descendants9 generations forward: 3 descendants10 generations forward: 2 descendants K954481 · P.F.C. Uni-Compartmental Knee System · Johnson & Johnson Professionals, Inc. · 19960+5+10
  1. Root · 1 generation backK954481 P.F.C. Uni-Compartmental Knee SystemJohnson & Johnson Professionals, Inc. · 1996
  2. This deviceK040268 Depuy Preservation Unicondylar TibiaDePuy Orthopaedics, Inc. · 2004
  3. Descendant · cites it directly · 32 of its ownK063432 Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · Recalled
  4. Descendant · cites it directly · 31 of its ownK072368 Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · Recalled
  5. Descendant · 2 generations on · 29 of its ownK092441 Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009
  6. Descendant · 2 generations on · 28 of its ownK111916 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011
  7. Descendant · 2 generations on · 27 of its ownK121974 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2007: 32008: 12009: 22010: 12011: 12012: 12013: 12014: 12016: 12017: 12019: 52020: 42021: 92022: 32023: 62024: 42025: 12026: 2
2007high 9 (2021) · low 0 (2015)2026

Most influential descendants

Showing 5 of 47 · See all
  • K063432Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · cites it directly32descendants
  • K072368Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · cites it directly31descendants
  • K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009 · 2 generations on29descendants
  • K111916Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011 · 2 generations on28descendants
  • K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012 · 2 generations on27descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K954481P.F.C. Uni-Compartmental Knee SystemJohnson & Johnson Professionals, Inc.1996—
0 (this device)K040268Depuy Preservation Unicondylar TibiaDePuy Orthopaedics, Inc.2004—
+1K063432Conformis Metal Backed Tibial Component (MBT)Conformis, Inc.20073
+1K072368Conformis Metal Backed Tibial ComponentConformis, Inc.20073
+2K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc.2009—
+2K111916Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.2011—
+2K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200730
200810
200920
201010
201110
201210
201310
201410
201610
201710
201950
202040
202190
202230
202360
202440
202510
202620
FIG. 1 — Lineage of K040268, 1996–2026Source: 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? (2)

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
*K010810Depuy Preservation Unicondylar Knee Prosthesis
Summary page 1
…ICE PRODUCT CODE: 87 HRY SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Preservation TM Unicondylar Knee System (K0108 10, cleared April 18, 2001) PFC® Sigma Uni-Compartmental Knee System…
DePuy Orthopaedics, Inc.200119
*K954481P.F.C. Uni-Compartmental Knee System
Summary page 1
…(K0108 10, cleared April 18, 2001) PFC® Sigma Uni-Compartmental Knee System (K954481, cleared October 10, 1996) DEVICE DESCRIPTION: TM The DePuy Preservation Unicondylar Tibia c…
Johnson & Johnson Professionals, Inc.1996—

Also cleared against K010810: 7 other devices →

What descends from it? (47)

See all 47

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

NumberDeviceApplicantDecidedDescendants
K063432Conformis Metal Backed Tibial Component (MBT)Conformis, Inc.200732
K072368Conformis Metal Backed Tibial ComponentConformis, Inc.200731
K070267Depuy GCK Tibial ComponentsDePuy Orthopaedics, Inc.200712
K101206TGS Unicompartmental Knee Arthroplasty (TGS Uka) Modular Tibia SystemAlexandria Research Technologies, LLC20100

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 15, 2006Not classifiedZ-0456-2007OtherChamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
Nov 15, 2006Not classifiedZ-0457-2007OtherChamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
Nov 15, 2006Not classifiedZ-0458-2007OtherChamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
Nov 15, 2006Not classifiedZ-0459-2007OtherChamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
Nov 15, 2006Not classifiedZ-0465-2007OtherChamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
Nov 15, 2006Not classifiedZ-0460-2007OtherChamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
Nov 15, 2006Not classifiedZ-0461-2007OtherChamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
Nov 15, 2006Not classifiedZ-0462-2007OtherChamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
Nov 15, 2006Not classifiedZ-0463-2007OtherChamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
Nov 15, 2006Not classifiedZ-0464-2007OtherChamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.

The 5 latest of 10 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K063432 (Conformis, Inc., 2007) has gone furthest, with 32 descendants of its own.
  • 7 other devices also cite its predicate K010810.

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?

The DePuy PreservationTM Unicondylar Knee is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Caution: This knee prosthesis component is intended for cemented use only. Candidates for unicondylar knee replacement include elderly patients with a severely painful and/or severely disabled joint…

Read the full statement (172 words)

The DePuy PreservationTM Unicondylar Knee is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Caution: This knee prosthesis component is intended for cemented use only.

Candidates for unicondylar knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. In candidates for unicondylar knee arthroplasty, only one side of the joint (the medial or lateral compartmental) is affected. Unicondylar knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives.

Indications for use as stated in the FDA summary.

Also cleared against K010810

7 other devices cite the same predicate.

  • K090024TGS Unicompartmental Knee Arthroplasty SystemAlexandria Research Technologies, LLC · 2009
  • K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 20061 recall
  • K053299Repicci II Onlay Unicompartmental Tibial ComponentBiomet Manufacturing, Inc. · 2006
  • K040889Exactech Optetrak Unicondylar KneeExactech, Inc. · 20041 recall
  • K033810Natural-Knee II Unicompartmental Knee SystemCenterpulse Orthopedics, Inc. · 20041 recall
  • K022437Uni KneeEncore Medical L.P. · 20022 recalls

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/K040268 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040268: Depuy Preservation Unicondylar Tibia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040268

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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