510(k) · Cleared
ClearedConstrained Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on Apr 1, 2003 as substantially equivalent to K950202 (Biomet, Inc., 1995) and 2 other predicates after a 139-day review. Its family tree reaches back 2 generations to 1997. 15 later devices descend from it.
- Decided
- Apr 1, 2003
- Review
- 139 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to P960054 (1997). 3 ancestors in all, the oldest K950202 (1995). 15 later devices descend from it, 2 citing it directly.
- Root · 2 generations backP960054 S-Rom Poly-Dial Constrained LinerDepuy, A Johnson & Johnson Co. · 1997
- 1 generation backK021826 Trilogy Acetabular System Constrained Liner, Model 6154 SeriesZimmer, Inc. · 2002
- This deviceK023794 Constrained LinerEncore Medical L.P. · 2003
- Descendant · cites it directly · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
- Descendant · 2 generations on · 4 of its ownK152903 REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016
- Descendant · 2 generations on · 4 of its ownK140975 Mastersl Femoral StemLima Corporate S.P.A. · 2014
- Descendant · 2 generations on · 3 of its ownK191374 Revival Modular Hip StemCorin U.S.A. Limited · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · cites it directly13descendants
- K141327Minima S SystemLima Corporate S.P.A. · 2014 · 2 generations on5descendants
- K152903REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016 · 2 generations on4descendants
- K140975Mastersl Femoral StemLima Corporate S.P.A. · 2014 · 2 generations on4descendants
- K191374Revival Modular Hip StemCorin U.S.A. Limited · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P960054 | S-Rom Poly-Dial Constrained Liner | Depuy, A Johnson & Johnson Co. | 1997 | — |
| −1 | K021826 | Trilogy Acetabular System Constrained Liner, Model 6154 Series | Zimmer, Inc. | 2002 | — |
| 0 (this device) | K023794 | Constrained Liner | Encore Medical L.P. | 2003 | — |
| +1 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +2 | K141327 | Minima S System | Lima Corporate S.P.A. | 2014 | — |
| +2 | K152903 | REVIVAL (TM) Modular Revision Hip Stem | Corin USA | 2016 | — |
| +2 | K140975 | Mastersl Femoral Stem | Lima Corporate S.P.A. | 2014 | — |
| +2 | K191374 | Revival Modular Hip Stem | Corin U.S.A. Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K950202 | Ringloc Constrained LinerSummary page 2…e FMP Constrained Liner. Predicate Device The FMP Constrained liner is similar or identical in regards to material, design, sizing, and indications to Biomet’s RingLoc (K950202), Poly-Dial - Johnson 8z Johnson (P960054) and Trilogy - Zimmer (KO2 1826). DEPARTMENT OF HEALTH & HUMAN SERV… | 1995 |
| * | P960054 | S-Rom Poly-Dial Constrained LinerSummary page 2…The FMP Constrained liner is similar or identical in regards to material, design, sizing, and indications to Biomet’s RingLoc (K950202), Poly-Dial - Johnson 8z Johnson (P960054) and Trilogy - Zimmer (KO2 1826). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 1997 |
| * | K021826 | Trilogy Acetabular System Constrained Liner, Model 6154 Series Cleared while this submission was under review | 2002 |
What descends from it? (15)
See all 152 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 6 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112158 (Lima Corporate S.P.A., 2012) has gone furthest, with 13 descendants of its own.
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.
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 FMP Constrained Liner is intended to replace a hip joint. The device is intended for primary or revision patients at high risk of 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023794 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023794: Constrained Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023794
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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