510(k) · Cleared
ClearedTrabecular Metal Acetabular Revision System Cemented Contrained Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on Jan 7, 2008 as substantially equivalent to K051516 (Zimmer, Inc., 2005) after a 159-day review. Its family tree reaches back 2 generations to 1998. 3 later devices descend from it.
- Decided
- Jan 7, 2008
- Review
- 159 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983128 (1998). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK983128 Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy…Implex Corp. · 1998 · Recalled
- 1 generation backK051516 Trabecular Metal Revision Shell LinersZimmer, Inc. · 2005
- This deviceK072121 Trabecular Metal Acetabular Revision System Cemented Contrained LinerZimmer, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK181366 REDAPT Porous Acetabular ShellSmith & Nephew, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK243571 Trabecular Metal Acetabular Revision System, Acetabular Liners and…Zimmer Biomet · 2025
- Descendant · 2 generations on · 0 of its ownK242744 Trinity EVO Acetabular ShellCorin U.S.A. Limited · 2025
Most influential descendants
Showing 3 of 3 · See all- K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc. · 2018 · cites it directly1descendant
- K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025 · cites it directly0descendants
- K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983128 | Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy… | Implex Corp. | 1998 | 1 |
| −1 | K051516 | Trabecular Metal Revision Shell Liners | Zimmer, Inc. | 2005 | — |
| 0 (this device) | K072121 | Trabecular Metal Acetabular Revision System Cemented Contrained Liner | Zimmer, Inc. | 2008 | — |
| +1 | K181366 | REDAPT Porous Acetabular Shell | Smith & Nephew, Inc. | 2018 | — |
| +1 | K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained… | Zimmer Biomet | 2025 | — |
| +2 | K242744 | Trinity EVO Acetabular Shell | Corin U.S.A. Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 2 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
What descends from it? (3)
2 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 10 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K181366 (Smith & Nephew, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K051516.
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. 2008, 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 Trabecular Metal Acetabular Revision System (TMARS) Cemented Constrained Liner is intended to be cemented to a TMARS shell; the shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in 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 intraoperative instability and for whom all other options to constrained acetabular components have been considered.
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/K072121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072121: Trabecular Metal Acetabular Revision System Cemented Contrained Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072121
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