510(k) · Cleared
ClearedSmith & Nephew RJ Constrained Liners
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 Sep 9, 2011 as substantially equivalent to K083566 (Smith & Nephew, Inc., 2009) after an 88-day review. Its family tree reaches back 2 generations to 1997. 4 later devices descend from it.
- Decided
- Sep 9, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P960047 (1997). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
- 1 generation backK083566 R3 Constrained Liner, Constrained LinerSmith & Nephew, Inc. · 2009 · Recalled
- This deviceK111635 Smith & Nephew RJ Constrained LinersSmith & Nephew, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK241461 Mpact Constrained LinerMedacta International S.A. · 2025
- Descendant · cites it directly · 1 of its ownK122139 Smith & Nephew R3 Constrained LinersSmith & Nephew, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
- Descendant · cites it directly · 0 of its ownK162641 Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K241461Mpact Constrained LinerMedacta International S.A. · 2025 · cites it directly1descendant
- K122139Smith & Nephew R3 Constrained LinersSmith & Nephew, Inc. · 2012 · cites it directly1descendant
- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · 2 generations on0descendants
- K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P960047 | Osteonics Constrained Acetabular Insert | Howmedica Osteonics Corp. | 1997 | — |
| −1 | K083566 | R3 Constrained Liner, Constrained Liner | Smith & Nephew, Inc. | 2009 | 13 |
| 0 (this device) | K111635 | Smith & Nephew RJ Constrained Liners | Smith & Nephew, Inc. | 2011 | — |
| +1 | K241461 | Mpact Constrained Liner | Medacta International S.A. | 2025 | — |
| +1 | K122139 | Smith & Nephew R3 Constrained Liners | Smith & Nephew, Inc. | 2012 | — |
| +2 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
| +1 | K162641 | Smith & Nephew, Inc. R3™ Constrained Liner | Smith & Nephew, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 | Decided |
|---|---|---|---|
| * | K083566 | R3 Constrained Liner, Constrained LinerSummary page 1…rthopaedics/87 Product Code: KWZ Device Description The R3 Constrained Liners were previously cleared for market via premarket notification K083566. In August of 2010, Smith & Nephew launched a voluntary recall of the devices due to reports of intraoperative dislocations.-The-… | 2009 |
| * | — | Reflection Constrained Liners Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K241461 (Medacta International S.A., 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K083566.
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. 2011, 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111635: Smith & Nephew RJ Constrained Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111635
Report an extraction error
Are you the manufacturer?
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