510(k) · Cleared

Recalled · Class II · 2022

ATTUNE Revision Knee System

K160700510(k) TraditionalCleared Jun 10, 201688-day reviewClass II21 CFR 888.3560Recalls 5

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

Depuy (Ireland) · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jun 10, 2016 as substantially equivalent to K111433 (DePuy Orthopaedics, Inc., 2011) and 1 other predicate after an 88-day review. Its family tree reaches back 5 generations to 1994. 6 later devices descend from it. It has been recalled 5 times.

Decided: Jun 10, 2016
Review: 88 days
Class: Class II
Product code: JWH
Recalls: 5
Predicates: 2

Its longest line of descent runs back 5 generations to K943462 (1994). 15 ancestors in all, the oldest K922620 (1992). 6 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 5 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
4 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
3 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
2 generations backK101433 Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010
1 generation backK111433 Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc. · 2011 · Recalled
This deviceK160700 ATTUNE Revision Knee SystemDepuy (Ireland) · 2016
Descendant · cites it directly · 2 of its ownK240683 Rx Knee SystemSignature Orthopaedics Pty, Ltd. · 2024
Descendant · 2 generations on · 0 of its ownK260063 GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
Descendant · cites it directly · 0 of its ownK262130 ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026
Descendant · 2 generations on · 0 of its ownK261734 Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc. · 2026
Descendant · cites it directly · 0 of its ownK241000 ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal…Depuy Ireland UC · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2019high 3 (2026) · low 0 (2020)2026

Most influential descendants

Showing 5 of 6 · See all

K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd. · 2024 · cites it directly2descendants
K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026 · 2 generations on0descendants
K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026 · cites it directly0descendants
K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc. · 2026 · 2 generations on0descendants
K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K943462	Darwin Knee System	Johnson & Johnson Professionals, Inc.	1994	8
−4	K033272	Depuy Sigma Tibial Inserts	DePuy Orthopaedics, Inc.	2004	51
−3	K040166	Depuy Sigma XLK Tibial Inserts	DePuy Orthopaedics, Inc.	2004	—
−2	K101433	Depuy Attune Knee System	DePuy Orthopaedics, Inc.	2010	—
−1	K111433	Depuy Sttune (TM) PS Knee System	DePuy Orthopaedics, Inc.	2011	1
0 (this device)	K160700	ATTUNE Revision Knee System	Depuy (Ireland)	2016	—
+1	K240683	Rx Knee System	Signature Orthopaedics Pty, Ltd.	2024	—
+2	K260063	GSPE Spacer	The General Hospital Corporation, d/b/a Massachusetts	2026	—
+1	K262130	ATTUNE Revision Knee System	Depuy Orthopaedics, Inc.	2026	—
+2	K261734	Klassic Infection Spacer System	Total Joint Orthopedics, Inc.	2026	—
+1	K241000	ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem…	Depuy Ireland UC	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1995	2	0
1996	3	0
1997	1	0
2003	1	0
2008	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2024	2	0
2026	3	0

FIG. 1 — Lineage of K160700, 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 JWH? 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 JWH device

#1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K111433	Depuy Sttune (TM) PS Knee System Summary page 4 …equivalent to legally marketed devices including: Primary Predicates: x ATTUNE Total Knee System (Posterior Stabilized) –K111433* x Darwin Knee System (TC3) – K952830** Reference Predicates:…	DePuy Orthopaedics, Inc.	2011	1
*	K952830	Darwin Knee System (TC3) Summary page 4 …Primary Predicates: x ATTUNE Total Knee System (Posterior Stabilized) –K111433* x Darwin Knee System (TC3) – K952830** Reference Predicates: x ATTUNE Total Knee System (Cruciate Retaining) –K101433*…	Johnson & Johnson Professionals, Inc.	1996	8
†	K101433	Depuy Attune Knee System	DePuy Orthopaedics, Inc.	2010	—
†	K032151	Depuy Sigma Tibial Inserts and CO-CR Tibial Trays	Depuy, Inc.	2003	12
†	K063633	Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal Sleeves	DePuy Orthopaedics, Inc.	2007	1
†	K923807	P.F.C. Modular Total Knee System, Modular Plus	Johnson & Johnson International	1992	1
†	K060515	Depuy PFC Sigma Knee Prosthesis	DePuy Orthopaedics, Inc.	2006	—
†	K071417	Depuy LPS Diaphyseal and Metaphyseal Sleeves	DePuy Orthopaedics, Inc.	2007	Class I
†	K941769	Knee Prothesis	Joint Medical Products Corp.	1995	—
†	K070095	Triathlon TS Knee System	Howmedica Osteonics Corp.	2007	13

Also cleared against K111433: 7 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K240683	Rx Knee System	Signature Orthopaedics Pty, Ltd.	2024	2
K262130	ATTUNE Revision Knee System	Depuy Orthopaedics, Inc.	2026	0
K241000	ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…	Depuy Ireland UC	2024	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
Jan 5, 2022	Class II	Z-0631-2022	Nonconforming Material/Component	May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
Jan 5, 2022	Class II	Z-0632-2022	Nonconforming Material/Component	May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
Jul 1, 2021	Class II	Z-2348-2021	Process change control	Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
Apr 16, 2018	Class II	Z-1703-2018	Process control	There may be burrs on the extraction hole threads.
Apr 16, 2018	Class II	Z-1704-2018	Process control	There may be burrs on the extraction hole threads.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
9 of the 15 ancestors have a recall of any class.
Of its descendants, K240683 (Signature Orthopaedics Pty, Ltd., 2024) has gone furthest, with 2 descendants of its own.
7 other devices also cite its predicate K111433.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

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

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

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

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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	18	74	14	1,305
2008	17	81	10	1,483
2009	11	168	109	1,870
2010	19	85	32	3,286
2011	25	87	27	5,133
2012	33	85	85	5,203
2013	31	128	31	6,135
2014	33	98	13	6,722
2015	27	87	11	6,881
2016	18	88	17	7,586
2017	25	118	61	12,263
2018	25	90	14	14,071
2019	28	133	5	14,987
2020	22	59	2	12,592
2021	24	61	8	9,408
2022	17	56	12	8,364
2023	20	57	67	8,947
2024	19	89	7	10,828
2025	20	55	2	9,306
2026	12	63	4	—

What is it indicated for?

Candidates for total knee replacement include patients with: A severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis Moderate valgus, varus, or flexion deformities Avascular necrosis of the femoral condyle A previous unsuccessful knee replacement, osteotomy, or other knee procedure ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients…

Read the full statement (123 words)

Candidates for total knee replacement include patients with:

A severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis

Moderate valgus, varus, or flexion deformities

Avascular necrosis of the femoral condyle

A previous unsuccessful knee replacement, osteotomy, or other knee procedure

ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with:

Absence or loss of both cruciate ligaments

Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon

Bone loss that requires supplemental fixation in the clinical judgment of the surgeon

The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.

Any non porous-coated components are intended for cemented use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K160700 · printed Nov 4, 2026

Cite this page

510(k) Report. “K160700: ATTUNE Revision Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160700

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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