PMA · Approved
ApprovedS-Rom Poly-Dial Constrained Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, A Johnson & Johnson Co. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Approved on Jun 19, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 175-day review. 215 later devices descend from it.
- Decided
- Jun 19, 1997
- Review
- 175 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
215 later devices descend from it, 6 citing it directly.
- This deviceP960054 S-Rom Poly-Dial Constrained LinerDepuy, A Johnson & Johnson Co. · 1997
- Descendant · cites it directly · 184 of its ownK021728 Ringloc Constrained Liners IIBiomet, Inc. · 2002
- Descendant · 2 generations on · 181 of its ownK030047 Freedom Constrained LinersBiomet, Inc. · 2003
- Descendant · 3 generations on · 160 of its ownK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
- Descendant · 3 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- Descendant · 4 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
Showing 5 of 215 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 215 · See all- K021728Ringloc Constrained Liners IIBiomet, Inc. · 2002 · cites it directly184descendants
- K030047Freedom Constrained LinersBiomet, Inc. · 2003 · 2 generations on181descendants
- K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005 · 3 generations on160descendants
- K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · 3 generations on53descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 4 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P960054 | S-Rom Poly-Dial Constrained Liner | Depuy, A Johnson & Johnson Co. | 1997 | — |
| +1 | K021728 | Ringloc Constrained Liners II | Biomet, Inc. | 2002 | — |
| +2 | K030047 | Freedom Constrained Liners | Biomet, Inc. | 2003 | — |
| +3 | K043537 | Taperloc 12/14 Taper Femoral Components | Biomet, Inc. | 2005 | — |
| +3 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| +4 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 17 | 0 |
| 2013 | 8 | 0 |
| 2014 | 14 | 0 |
| 2015 | 10 | 0 |
| 2016 | 10 | 0 |
| 2017 | 11 | 0 |
| 2018 | 7 | 0 |
| 2019 | 19 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 12 | 0 |
| 2023 | 9 | 0 |
| 2024 | 15 | 0 |
| 2025 | 20 | 0 |
| 2026 | 19 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (215)
See all 2156 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021728 | Ringloc Constrained Liners II | 2002 | 184 |
| K021661 | Ringloc Constrained Liners | 2002 | 32 |
| K030923 | Epsilon Durasul Constrained Acetabular Liner | 2003 | 31 |
| K021826 | Trilogy Acetabular System Constrained Liner, Model 6154 Series | 2002 | 16 |
| K023794 | Constrained Liner | 2003 | 15 |
| K122139 | Smith & Nephew R3 Constrained Liners | 2012 | 1 |
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?
- Of its descendants, K021728 (Biomet, Inc., 2002) has gone furthest, with 184 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 | — |
https://510kreport.com/device/P960054 · printed Nov 4, 2026
Cite this page
510(k) Report. “P960054: S-Rom Poly-Dial Constrained Liner.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P960054
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026