510(k) · Cleared
ClearedSmith & Nephew, Inc. R3™ Constrained Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on Jun 19, 2017 as substantially equivalent to K111635 (Smith & Nephew, Inc., 2011) and 5 other predicates after a 270-day review. Its family tree reaches back 6 generations to 1986.
- Decided
- Jun 19, 2017
- Review
- 270 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K861766 (1986). 54 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK861766 Howmedica Hoffmann Fixation Pin SystemHowmedica Corp. · 1986
- 5 generations backK964094 MinifixFerguson Medical · 1996
- 4 generations backK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
- 3 generations backK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
- 2 generations backK092386 R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009
- 1 generation backK113848 R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · Recalled
- This deviceK162641 Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K861766 | Howmedica Hoffmann Fixation Pin System | Howmedica Corp. | 1986 | — |
| −5 | K964094 | Minifix | Ferguson Medical | 1996 | — |
| −4 | K061253 | Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2006 | — |
| −3 | K070756 | Smith and Nephew Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2007 | 6 |
| −2 | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners | Smith & Nephew, Inc. | 2009 | — |
| −1 | K113848 | R3 Xlpe Liners | Smith & Nephew, Inc. | 2012 | 2 |
| 0 (this device) | K162641 | Smith & Nephew, Inc. R3™ Constrained Liner | Smith & Nephew, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
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
What was it cleared against? (6)
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 | Decided |
|---|---|---|---|
| * | K111635 | Smith & Nephew RJ Constrained LinersSummary page 4…System. The R3 Constrained Liner Acetabular System currently consists of the R3 Constrained Liner offered in sizes of 52mm to 66/70mm cleared via premarket notification K111635. The proposed devices are additional sizes to the R3 Constrained Liners that were previously cleared. The proposed devices will b… | 2011 |
| * | K122139 | Smith & Nephew R3 Constrained LinersSummary page 4…ption that they are smaller or larger in overall size. The new R3 Constrained Liner sizes are also similar to the following additional predicates: R3 Constrained Liners (K122139), REFLECTION Constrained Liners (K021803, K033442), R3 XLPE Liners (K113848), and DePuy Self-Centering Hip Prostheses (K033273).… | 2012 |
| * | K021803 | Reflection Constrained LinerSummary page 4…overall size. The new R3 Constrained Liner sizes are also similar to the following additional predicates: R3 Constrained Liners (K122139), REFLECTION Constrained Liners (K021803, K033442), R3 XLPE Liners (K113848), and DePuy Self-Centering Hip Prostheses (K033273). The subject devices are also similar to r… | 2002 |
| * | K033442 | Reflection Constrained LinerSummary page 4…ize. The new R3 Constrained Liner sizes are also similar to the following additional predicates: R3 Constrained Liners (K122139), REFLECTION Constrained Liners (K021803, K033442), R3 XLPE Liners (K113848), and DePuy Self-Centering Hip Prostheses (K033273). The subject devices are also similar to reference… | 2003 |
| * | K113848 | R3 Xlpe LinersSummary page 4…d Liner sizes are also similar to the following additional predicates: R3 Constrained Liners (K122139), REFLECTION Constrained Liners (K021803, K033442), R3 XLPE Liners (K113848), and DePuy Self-Centering Hip Prostheses (K033273). The subject devices are also similar to reference predicate Osteonics Constr… | 2012 |
| * | K033273 | Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima…Summary page 4…itional predicates: R3 Constrained Liners (K122139), REFLECTION Constrained Liners (K021803, K033442), R3 XLPE Liners (K113848), and DePuy Self-Centering Hip Prostheses (K033273). The subject devices are also similar to reference predicate Osteonics Constrained Acetabular Inserts (P960047). The subject dev… | 2004 |
| † | P960047 | Osteonics Constrained Acetabular Insert | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 14 of the 54 ancestors have a recall of any class.
- 2 other devices also cite its predicate K111635.
How does its category compare?
All KWZ devicesKWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWZ
104in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWZ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWZ
193in 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 an 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 intraoperative 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162641 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162641: Smith & Nephew, Inc. R3™ Constrained Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162641
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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