510(k) · Cleared

Recalled · Class II · 2023

Depuy Sttune (TM) PS Knee System

K111433510(k) TraditionalCleared Aug 30, 201199-day reviewClass II21 CFR 888.3560Recalls 1

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 Aug 30, 2011 as substantially equivalent to K101433 (DePuy Orthopaedics, Inc., 2010) and 4 other predicates after a 99-day review. Its family tree reaches back 4 generations to 1994. 39 later devices descend from it. It has been recalled once.

Decided: Aug 30, 2011
Review: 99 days
Class: Class II
Product code: OIY
Recalls: 1
Predicates: 5

Its longest line of descent runs back 4 generations to K943462 (1994). 13 ancestors in all, the oldest K922620 (1992). 39 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 4 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
3 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
2 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
1 generation backK101433 Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010
This deviceK111433 Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc. · 2011
Descendant · cites it directly · 26 of its ownK140833 Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014
Descendant · 2 generations on · 24 of its ownK142404 iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
Descendant · 2 generations on · 24 of its ownK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled
Descendant · 3 generations on · 23 of its ownK152704 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate…Conformis, Inc. · 2015
Descendant · 3 generations on · 20 of its ownK160025 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal…Conformis, Inc. · 2016 · Recalled

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2014high 6 (2016) · low 0 (2017)2026

Most influential descendants

Showing 5 of 39 · See all

K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · cites it directly26descendants
K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 2 generations on24descendants
K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc. · 2014 · 2 generations on24descendants
K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc. · 2015 · 3 generations on23descendants
K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc. · 2016 · 3 generations on20descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K943462	Darwin Knee System	Johnson & Johnson Professionals, Inc.	1994	8
−3	K033272	Depuy Sigma Tibial Inserts	DePuy Orthopaedics, Inc.	2004	51
−2	K040166	Depuy Sigma XLK Tibial Inserts	DePuy Orthopaedics, Inc.	2004	—
−1	K101433	Depuy Attune Knee System	DePuy Orthopaedics, Inc.	2010	—
0 (this device)	K111433	Depuy Sttune (TM) PS Knee System	DePuy Orthopaedics, Inc.	2011	—
+1	K140833	Itotal Posterior Stabilized (PS) Knee Replacement System	Conformis, Inc.	2014	—
+2	K142404	iTotal Posterior Stabilized (PS) Knee Replacement System	Conformis, Inc.	2014	2
+2	K142161	Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior…	Conformis, Inc.	2014	6
+3	K152704	iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining…	Conformis, Inc.	2015	—
+3	K160025	iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate…	Conformis, Inc.	2016	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1995	2	0
1996	2	0
1997	1	0
2003	1	0
2008	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	3	0
2015	2	0
2016	6	0
2018	1	0
2019	2	0
2020	4	0
2021	5	0
2022	2	0
2023	5	0
2024	3	0
2025	1	0
2026	5	0

FIG. 1 — Lineage of K111433, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K252887 DePuy ATTUNE™ Knee Systemscore 12.6 · 5 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K101433	Depuy Attune Knee System Summary page 1 …the DePuy Attune Knee System, are substantially equivalent to currently marketed devices indluding: * Attune Knee System, K101433 * Sigma Tibial Inserts, 1(033272 " Sigma XLK Tibial Inserts, K(040166…	DePuy Orthopaedics, Inc.	2010	—
*	K033272	Depuy Sigma Tibial Inserts Summary page 1 …ntially equivalent to currently marketed devices indluding: * Attune Knee System, K101433 * Sigma Tibial Inserts, 1(033272 " Sigma XLK Tibial Inserts, K(040166 * Sigma PS Femoral Components, K(073…	DePuy Orthopaedics, Inc.	2004	51
*	K040166	Depuy Sigma XLK Tibial Inserts Summary page 1 …* Attune Knee System, K101433 * Sigma Tibial Inserts, 1(033272 " Sigma XLK Tibial Inserts, K(040166 * Sigma PS Femoral Components, K(073529 * Zimmer NexGen LPS Femoral Compo…	DePuy Orthopaedics, Inc.	2004	—
*	K073529	Depuy Sigma PS Femoral Components Summary page 1 …* Sigma Tibial Inserts, 1(033272 " Sigma XLK Tibial Inserts, K(040166 * Sigma PS Femoral Components, K(073529 * Zimmer NexGen LPS Femoral Components /Articular Surfaces, K(960279 D…	DePuy Orthopaedics, Inc.	2008	—
*	K960279	Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral… Summary page 1 …* Sigma PS Femoral Components, K(073529 * Zimmer NexGen LPS Femoral Components /Articular Surfaces, K(960279 Device Description- The AttuneTM posterior stabilized (PS) femoral components have an asymmetric trochicar g…	Zimmer, Inc.	1996	21

Also cleared against K101433: 14 other devices →

What descends from it? (39)

See all 39

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

Number	Device	Applicant	Decided	Descendants
K140833	Itotal Posterior Stabilized (PS) Knee Replacement System	Conformis, Inc.	2014	26
K160700	ATTUNE Revision Knee System	Depuy (Ireland)	2016	6
K140881	Depuy Attune Knee System - Cementless CR and PS Femoral Componenets	Depuy (Ireland)	2015	3
K261458	ATTUNE Total Knee System; ATTUNE Cementless Knee System	DePuy Ireland UC	2026	0
K252887	DePuy ATTUNE™ Knee System	DePuy Orthopaedics, Inc.	2026	0
K233980	ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…	Depuy Ireland UC	2024	0
K201347	DePuy ATTUNE™ Total Knee System	DePuy Orthopaedics, Inc.	2020	0
K191779	Attune Revision LPS Inserts	Depuy (Ireland)	2019	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 15, 2023	Class II	Z-1267-2023	Labeling Change Control	The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant…

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.
7 of the 13 ancestors have a recall of any class.
Of its descendants, K140833 (Conformis, Inc., 2014) has gone furthest, with 26 descendants of its own.
14 other devices also cite its predicate K101433.

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

2007high 4 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OIY

132in 2010

2007high 132 (2010)2026

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

Recalls per year · OIY

1in 2015

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	4	132	0	0
2011	2	—	0	0
2012	2	—	0	6
2013	1	—	0	16
2014	0	—	1	84
2015	0	—	1	282
2016	0	—	0	130
2017	0	—	0	91
2018	0	—	0	68
2019	0	—	0	78
2020	1	—	0	121
2021	0	—	0	379
2022	0	—	0	42
2023	0	—	0	40
2024	1	—	0	34
2025	0	—	0	35
2026	1	—	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.

https://510kreport.com/device/K111433 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111433: Depuy Sttune (TM) PS 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/K111433

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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