510(k) Report

510(k) · Cleared

Cleared

Depuy Attune Total Knee System

K103756510(k) TraditionalCleared Mar 15, 201182-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 Mar 15, 2011 as substantially equivalent to K950010 (Johnson & Johnson Professionals, Inc., 1995) and 4 other predicates after an 82-day review. Its family tree reaches back 4 generations to 1994. 7 later devices descend from it.

Decided
Mar 15, 2011
Review
82 days
Class
Class II
Product code
OIY
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K943462 (1994). 12 ancestors in all, the oldest K910500 (1991). 7 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 2 other ancestors1991: 1 other ancestor2008: 1 other ancestor2003: 1 other ancestor1992: 1 other ancestor1997: 1 other ancestor2020: 2 descendants cleared2024: 2 descendants cleared2023: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant clearedK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled×2: 2 generations cleared close together, K033272 (2004), K040166 (2004) K101433 · Depuy Attune Knee System · DePuy Orthopaedics, Inc. · 20101990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants K101433 · Depuy Attune Knee System · DePuy Orthopaedics, Inc. · 2010K040166 · 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
  1. Root · 4 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
  2. 3 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
  3. 2 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
  4. 1 generation backK101433 Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010
  5. This deviceK103756 Depuy Attune Total Knee SystemDePuy Orthopaedics, Inc. · 2011
  6. Descendant · cites it directly · 4 of its ownK202194 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella…Depuy Ireland UC · 2020 · Recalled
  7. Descendant · 2 generations on · 1 of its ownK232303 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella…Depuy Ireland UC · 2023 · Recalled
  8. Descendant · 2 generations on · 0 of its ownK261458 ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC · 2026
  9. Descendant · cites it directly · 0 of its ownK242665 DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc. · 2024
  10. Descendant · 2 generations on · 0 of its ownK240678 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella…Depuy Ireland UC · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2020: 22022: 12023: 12024: 22026: 1
2020high 2 (2020) · low 0 (2021)2026

Most influential descendants

Showing 5 of 7 · See all
  • K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC · 2020 · cites it directly4descendants
  • K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC · 2023 · 2 generations on1descendant
  • K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC · 2026 · 2 generations on0descendants
  • K242665DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc. · 2024 · cites it directly0descendants
  • K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K943462Darwin Knee SystemJohnson & Johnson Professionals, Inc.19948
−3K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc.200451
−2K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc.2004—
−1K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc.2010—
0 (this device)K103756Depuy Attune Total Knee SystemDePuy Orthopaedics, Inc.2011—
+1K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and…Depuy Ireland UC20201
+2K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and…Depuy Ireland UC20231
+2K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC2026—
+1K242665DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc.2024—
+2K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and…Depuy Ireland UC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199210
199520
199610
199710
200310
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202210
202310
202420
202610
FIG. 1 — Lineage of K103756, 1994–2026Source: 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 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? (5)

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
*K950010Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated
Summary page 1
…are substantially equivalent to currently marketed devices including: * Sigma Patella (cleared as the Darwin Knee System), K950010 * PFC Cruciate Retaining Knee System, Size 1.5, K961685 * Attune Modified Dome…
Johnson & Johnson Professionals, Inc.199516
*K961685P.F.C. Cruciate Retaining Knee System (Size 1.5)
Summary page 1
…including: * Sigma Patella (cleared as the Darwin Knee System), K950010 * PFC Cruciate Retaining Knee System, Size 1.5, K961685 * Attune Modified Dome Patella, K101433 " Kinemax Plus Patella, K910500…
Johnson & Johnson Professionals, Inc.19967
*K101433Depuy Attune Knee System
Summary page 1
…he Darwin Knee System), K950010 * PFC Cruciate Retaining Knee System, Size 1.5, K961685 * Attune Modified Dome Patella, K101433 " Kinemax Plus Patella, K910500 * Zimmer NexGen CR Knee System, K933785 Device…
DePuy Orthopaedics, Inc.2010—
*K910500Howmedica Kinemax Plus Total Knee System
Summary page 1
…* PFC Cruciate Retaining Knee System, Size 1.5, K961685 * Attune Modified Dome Patella, K101433 " Kinemax Plus Patella, K910500 * Zimmer NexGen CR Knee System, K933785 Device Description: The Attune medialized dome and medialized…
Howmedica Corp.1991—
*K933785Next Generation Knee System
Summary page 1
…* Attune Modified Dome Patella, K101433 " Kinemax Plus Patella, K910500 * Zimmer NexGen CR Knee System, K933785 Device Description: The Attune medialized dome and medialized anatomic patellae are available in sizes 2…
Zimmer, Inc.199583

Also cleared against K950010: 9 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC20204
K242665DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc.20240
K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc.20200

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 17 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
  • 6 of the 12 ancestors have a recall of any class.
  • Of its descendants, K202194 (Depuy Ireland UC, 2020) has gone furthest, with 4 descendants of its own.
  • 9 other devices also cite its predicate K950010.

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. 2011, 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 AttuneTm Total 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 K950010

9 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
  • K102578Apex PS Knee SystemOmni Life Science, Inc. · 2011
  • K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010

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/K103756 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103756: Depuy Attune Total 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/K103756

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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