510(k) Report

510(k) · Cleared

Cleared

Depuy Attune Knee System

K101433510(k) TraditionalCleared Dec 10, 2010203-day reviewClass II21 CFR 888.3560

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

DePuy Orthopaedics, Inc. · OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Cleared on Dec 10, 2010 as substantially equivalent to K943462 (Johnson & Johnson Professionals, Inc., 1994) and 7 other predicates after a 203-day review. Its family tree reaches back 3 generations to 1994. 114 later devices descend from it.

Decided
Dec 10, 2010
Review
203 days
Class
Class II
Product code
OIY
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K943462 (1994). 10 ancestors in all, the oldest K922620 (1992). 114 later devices descend from it, 15 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2003: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors1992: 1 other ancestor1997: 1 other ancestor2020: 15 descendants cleared2012: 1 descendant cleared2015: 4 descendants cleared2011: 2 descendants cleared2021: 12 descendants cleared2024: 17 descendants cleared2019: 7 descendants cleared2017: 1 descendant cleared2026: 13 descendants cleared2016: 6 descendants cleared2014: 4 descendants cleared2022: 9 descendants cleared2018: 5 descendants cleared2013: 1 descendant cleared2023: 9 descendants cleared2025: 8 descendants clearedK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled×2: 2 generations cleared close together, K033272 (2004), K040166 (2004) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 1 other ancestor 1 generation forward: 15 descendants2 generations forward: 23 descendants3 generations forward: 23 descendants4 generations forward: 24 descendants5 generations forward: 12 descendants6 generations forward: 6 descendants7 generations forward: 4 descendants8 generations forward: 2 descendants9 generations forward: 3 descendants10 generations forward: 1 descendant11 generations forward: 1 descendant K040166 · Depuy Sigma XLK Tibial Inserts · DePuy Orthopaedics, Inc. · 2004K033272 · Depuy Sigma Tibial Inserts · DePuy Orthopaedics, Inc. · 2004 · recalledK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled0+5+10
  1. Root · 3 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
  2. 2 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
  3. 1 generation backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
  4. This deviceK101433 Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010
  5. Descendant · cites it directly · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
  6. Descendant · cites it directly · 39 of its ownK111433 Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc. · 2011 · Recalled
  7. Descendant · 2 generations on · 26 of its ownK140833 Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014
  8. Descendant · 3 generations on · 24 of its ownK142404 iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
  9. Descendant · 3 generations on · 24 of its ownK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled

Showing 5 of 114 descendants. See all descendants

Descendants cleared per year

2011: 22012: 12013: 12014: 42015: 42016: 62017: 12018: 52019: 72020: 152021: 122022: 92023: 92024: 172025: 82026: 13
2011high 17 (2024) · low 1 (2012)2026

Most influential descendants

Showing 5 of 114 · See all
  • K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · cites it directly59descendants
  • K111433Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc. · 2011 · cites it directly39descendants
  • K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 2 generations on26descendants
  • K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 3 generations on24descendants
  • K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc. · 2014 · 3 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K943462Darwin Knee SystemJohnson & Johnson Professionals, Inc.19948
−2K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc.200451
−1K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc.2004—
0 (this device)K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc.2010—
+1K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.20122
+1K111433Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc.20111
+2K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014—
+3K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.20142
+3K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior…Conformis, Inc.20146

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199520
199610
199710
200310
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201310
201440
201540
201660
201710
201850
201970
2020150
2021120
202290
202390
2024170
202580
2026130
FIG. 1 — Lineage of K101433, 1994–2026Source: 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), 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 OIY? 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 OIY device

  1. #1 K252887 DePuy ATTUNE™ Knee Systemscore 12.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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
*K943462Darwin Knee System
Summary page 3
…Characteristic Cornponent Femoral Component (K943462, K961685), PFC Sigma CR150 Femoral…
Johnson & Johnson Professionals, Inc.19948
*K950010Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated
Summary page 1
…ee System (cleared as the Darwin Knee System), K(943462 " Sigma Patella (cleared as the Darwin Knee System), K(950010 * PFC Cruciate Retaining Knee System, Size 1.5, K(961685 " Sigma Co-Cr…
Johnson & Johnson Professionals, Inc.199516
*K961685P.F.C. Cruciate Retaining Knee System (Size 1.5)
Summary page 3
…Characteristic Cornponent Femoral Component (K943462, K961685), PFC Sigma CR150 Femoral…
Johnson & Johnson Professionals, Inc.19967
*K032151Depuy Sigma Tibial Inserts and CO-CR Tibial Trays
Summary page 1
…n Knee System), K(950010 * PFC Cruciate Retaining Knee System, Size 1.5, K(961685 " Sigma Co-Cr Tibial Trays, K(032151 " Sigma XLK Tibial Inserts, K(040166 " Sigma CR 150 Femoral Compone…
Depuy, Inc.200312
*K040166Depuy Sigma XLK Tibial Inserts
Summary page 3
…Characteristic Tibial Inserts PLI Tibiall Inserts (K040166) Material AOX UHMWPE conforming XLK UI-IMWPXE conforming…
DePuy Orthopaedics, Inc.2004—
*K082500Depuy Sigma CR-F Femoral Component
Summary page 3
…Sigma CR150 Femoral Component (K082500), and Nex~en (K933785) Ma…
DePuy Orthopaedics, Inc.2008—
*K933785Next Generation Knee System
Summary page 3
…Component (K082500), and Nex~en (K933785) Material Cast Co-Cr-Mo alloy Cast Co-Cr-Mo alloy…
Zimmer, Inc.199583
*K922620Amk Fixed Stem Cemented Tibial Tray
Summary page 1
…150 Femoral Components, K(082500 * Zimmer NexGen CR Knee System, K(933785 " AMK® Fixed Stem Tibia] Tray, 1(922620 Device Description: The Attune TMfemoral components are available in a cruciate retaining (CR) version…
Depuy, Inc.1992—

Also cleared against K943462: 11 other devices →

What descends from it? (114)

See all 114

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

NumberDeviceApplicantDecidedDescendants
K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.201259
K111433Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc.201139
K192507LOSPA II Knee SystemCorentec Co., Ltd.20197
K103756Depuy Attune Total Knee SystemDePuy Orthopaedics, Inc.20117
K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC20204
K140881Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland)20153
K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212
K170806ATTUNE Cemented Tibial Base, Fixed BearingDepuy (Ireland)20172
K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260
K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc.20260

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 16 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
  • 6 of the 10 ancestors have a recall of any class.
  • Of its descendants, K121771 (Zimmer, Inc., 2012) has gone furthest, with 59 descendants of its own.
  • 11 other devices also cite its predicate K943462.

How does its category compare?

All OIY devices

OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · OIY

1in 2024

2010: 42011: 22012: 22013: 12020: 12024: 12026 (partial year): 1
2007high 4 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OIY

132in 2010

2010: 132 days median
2007high 132 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OIY

1in 2015

2014: 12015: 1
2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OIY

35in 2025

2012: 62013: 162014: 842015: 2822016: 1302017: 912018: 682019: 782020: 1212021: 3792022: 422023: 402024: 342025: 35
2007high 379 (2021) · low 0 (2007)2025

MAUDE reports naming product code OIY, 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
20070—00
20080—00
20090—00
2010413200
20112—00
20122—06
20131—016
20140—184
20150—1282
20160—0130
20170—091
20180—068
20190—078
20201—0121
20210—0379
20220—042
20230—040
20241—034
20250—035
20261—0—

What is it indicated for?

The DePuy Attune Knee System is intended for cemented use as a total knee replacement system.

Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

Indications for use as stated in the FDA summary.

Also cleared against K943462

11 other devices cite the same predicate.

  • K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral…Depuy Ireland UC · 2024
  • K193057ATTUNE All-Polyethylene TibiaDepuy Ireland UC · 2020
  • K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc. · 2019
  • K150496Total Knee Arthroplasty SystemResponsive Orthopedics, LLC · 201512 recalls
  • K082500Depuy Sigma CR-F Femoral ComponentDePuy Orthopaedics, Inc. · 2008
  • K062654Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc. · 2006

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 OIY

The OIY category page

  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026
  • K242665DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc. · 2024
  • K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc. · 2020
  • K120038A200 Knee SystemRenovis Surgical Technologies, LLC · 2013
  • K121727Movation Knee SystemEncore Medical L.P. · 2012

https://510kreport.com/device/K101433 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101433: Depuy Attune Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101433

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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