510(k) · Cleared
ClearedTrabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Biomet · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jul 31, 2025 as substantially equivalent to K051516 (Zimmer, Inc., 2005) and 1 other predicate after a 255-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Jul 31, 2025
- Review
- 255 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K983128 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK983128 Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy…Implex Corp. · 1998 · Recalled
- 2 generations backK051516 Trabecular Metal Revision Shell LinersZimmer, Inc. · 2005
- 1 generation backK072121 Trabecular Metal Acetabular Revision System Cemented Contrained LinerZimmer, Inc. · 2008
- This deviceK243571 Trabecular Metal Acetabular Revision System, Acetabular Liners and…Zimmer Biomet · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983128 | Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy… | Implex Corp. | 1998 | 1 |
| −2 | K051516 | Trabecular Metal Revision Shell Liners | Zimmer, Inc. | 2005 | — |
| −1 | K072121 | Trabecular Metal Acetabular Revision System Cemented Contrained Liner | Zimmer, Inc. | 2008 | — |
| 0 (this device) | K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained… | Zimmer Biomet | 2025 | — |
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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K051516 | Trabecular Metal Revision Shell LinersSummary page 5…oint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310) Predicate Device(s): Primary Predicate 510(k): K051516 Predicate Trade Name: Trabecular Metal Revision Shell Liners Product… | 2005 |
| * | K072121 | Trabecular Metal Acetabular Revision System Cemented Contrained LinerSummary page 5…Predicate Trade Name: Trabecular Metal Revision Shell Liners Product Code: JDI Additional Predicate 510(k): K072121 Predicate Trade Name: Trabecular Metal Acetabular Revision System Cem… | 2008 |
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 27 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K051516.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Acetabular Liners: The Trabecular Metal™ Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage. Constrained Liners: The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is intended to be cemented into a Trabecular Metal Acetabular Revision System shell; the shell is intended…
Read the full statement (134 words)
Acetabular Liners:
The Trabecular Metal™ Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage.
Constrained Liners:
The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is intended to be cemented into a Trabecular Metal Acetabular Revision System 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 complex 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/K243571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243571: Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243571
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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