510(k) · Cleared

Recalled · Class II · 2015

R3 Constrained Liner, Constrained Liner

K083566510(k) TraditionalCleared Mar 3, 200990-day reviewClass II21 CFR 888.3310Recalls 13

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

Smith & Nephew, Inc. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Cleared on Mar 3, 2009 as substantially equivalent to P960047 (Howmedica Osteonics Corp., 1997) after a 90-day review. Its family tree reaches back 1 generation to 1997. 10 later devices descend from it. It has been recalled 13 times.

Decided: Mar 3, 2009
Review: 90 days
Class: Class II
Product code: KWZ
Recalls: 13
Predicates: 1

Its longest line of descent runs back 1 generation to P960047 (1997). 10 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
This deviceK083566 R3 Constrained Liner, Constrained LinerSmith & Nephew, Inc. · 2009
Descendant · cites it directly · 4 of its ownK111635 Smith & Nephew RJ Constrained LinersSmith & Nephew, Inc. · 2011
Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
Descendant · 2 generations on · 1 of its ownK241461 Mpact Constrained LinerMedacta International S.A. · 2025
Descendant · 2 generations on · 1 of its ownK122139 Smith & Nephew R3 Constrained LinersSmith & Nephew, Inc. · 2012
Descendant · 3 generations on · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2011high 2 (2024) · low 0 (2014)2026

Most influential descendants

Showing 5 of 10 · See all

K111635Smith & Nephew RJ Constrained LinersSmith & Nephew, Inc. · 2011 · cites it directly4descendants
K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
K241461Mpact Constrained LinerMedacta International S.A. · 2025 · 2 generations on1descendant
K122139Smith & Nephew R3 Constrained LinersSmith & Nephew, Inc. · 2012 · 2 generations on1descendant
K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P960047	Osteonics Constrained Acetabular Insert	Howmedica Osteonics Corp.	1997	—
0 (this device)	K083566	R3 Constrained Liner, Constrained Liner	Smith & Nephew, Inc.	2009	—
+1	K111635	Smith & Nephew RJ Constrained Liners	Smith & Nephew, Inc.	2011	—
+1	K211176	Smith & Nephew Hip Systems	Smith & Nephew, Inc.	2022	1
+2	K241461	Mpact Constrained Liner	Medacta International S.A.	2025	—
+2	K122139	Smith & Nephew R3 Constrained Liners	Smith & Nephew, Inc.	2012	—
+3	K260173	M-Vizion Femoral Revision System Extension	Medacta International S.A.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2013	1	0
2017	1	0
2022	1	0
2023	1	0
2024	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K083566, 1997–2026Source: 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 KWZ? 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 KWZ device

#1 K241461 Mpact Constrained Linerscore 15.5 · 10 generations · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

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
*	P960047	Osteonics Constrained Acetabular Insert Summary page 1 …e',~''7,~~: Osteonics Constrained Osteonics Corporation Osteonics Cnst P960047 6/10/1997 AcetabularInsert Smith & Nephew, Inc. REFLECTION Constrain…	Howmedica Osteonics Corp.	1997	—
†	K021803	Reflection Constrained Liner	Smith & Nephew, Inc.	2002	—
†	K023743	Smith & Nephew Global Bipolar System	Smith & Nephew, Inc.	2003	3

Also cleared against P960047: 5 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K111635	Smith & Nephew RJ Constrained Liners	Smith & Nephew, Inc.	2011	4
K211176	Smith & Nephew Hip Systems	Smith & Nephew, Inc.	2022	3
K123598	Smith & Nephew, Inc. Hip System Instrumentation	Smith & Nephew, Inc.	2013	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 6, 2015	Class II	Z-1739-2015	Process change control	The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
May 6, 2015	Class II	Z-1735-2015	Process change control	The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
May 6, 2015	Class II	Z-1738-2015	Process change control	The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
May 6, 2015	Class II	Z-1736-2015	Process change control	The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
May 6, 2015	Class II	Z-1737-2015	Process change control	The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
Aug 13, 2010	Not classified	Z-0081-2011	Other	The firm received reports of a femoral head popping out of the liner intraoperatively.
Aug 13, 2010	Not classified	Z-0085-2011	Other	The firm received reports of a femoral head popping out of the liner intraoperatively.
Aug 13, 2010	Not classified	Z-0080-2011	Other	The firm received reports of a femoral head popping out of the liner intraoperatively.
Aug 13, 2010	Not classified	Z-0082-2011	Other	The firm received reports of a femoral head popping out of the liner intraoperatively.
Aug 13, 2010	Not classified	Z-0086-2011	Other	The firm received reports of a femoral head popping out of the liner intraoperatively.
Aug 13, 2010	Not classified	Z-0079-2011	Other	The firm received reports of a femoral head popping out of the liner intraoperatively.
Aug 13, 2010	Not classified	Z-0083-2011	Other	The firm received reports of a femoral head popping out of the liner intraoperatively.
Aug 13, 2010	Not classified	Z-0084-2011	Other	The firm received reports of a femoral head popping out of the liner intraoperatively.

The 5 latest of 13 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K111635 (Smith & Nephew, Inc., 2011) has gone furthest, with 4 descendants of its own.
5 other devices also cite its predicate P960047.

How does its category compare?

All KWZ devices

KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KWZ

1in 2025

2007high 7 (2007) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWZ

104in 2007

2007high 104 (2007)2026

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

Recalls per year · KWZ

1in 2023

2007high 8 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWZ

193in 2025

2007high 1,180 (2016) · low 41 (2007)2025

MAUDE reports naming product code KWZ, 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	7	104	0	41
2008	1	—	0	44
2009	1	—	0	81
2010	1	—	8	98
2011	1	—	0	127
2012	1	—	1	168
2013	0	—	0	274
2014	0	—	0	278
2015	0	—	0	636
2016	1	—	0	1,180
2017	2	—	0	477
2018	0	—	0	283
2019	0	—	0	532
2020	0	—	0	288
2021	0	—	0	216
2022	0	—	0	158
2023	0	—	1	164
2024	1	—	0	145
2025	1	—	0	193
2026	0	—	1	—

What is it indicated for?

The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083566 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083566: R3 Constrained Liner, Constrained Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083566

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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