510(k) · Cleared
ClearedTrabecular Metal Revision Shell Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jul 27, 2005 as substantially equivalent to K983128 (Implex Corp., 1998) after a 49-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it.
- Decided
- Jul 27, 2005
- Review
- 49 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983128 (1998). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK983128 Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy…Implex Corp. · 1998 · Recalled
- This deviceK051516 Trabecular Metal Revision Shell LinersZimmer, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK072121 Trabecular Metal Acetabular Revision System Cemented Contrained LinerZimmer, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK181366 REDAPT Porous Acetabular ShellSmith & Nephew, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK253630 Mpact 3D Metal FoamMedacta International S.A. · 2026
- Descendant · cites it directly · 0 of its ownK243571 Trabecular Metal Acetabular Revision System, Acetabular Liners and…Zimmer Biomet · 2025
- Descendant · 3 generations on · 0 of its ownK242744 Trinity EVO Acetabular ShellCorin U.S.A. Limited · 2025
Most influential descendants
Showing 5 of 5 · See all- K072121Trabecular Metal Acetabular Revision System Cemented Contrained LinerZimmer, Inc. · 2008 · cites it directly3descendants
- K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc. · 2018 · 2 generations on1descendant
- K253630Mpact 3D Metal FoamMedacta International S.A. · 2026 · cites it directly0descendants
- K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025 · cites it directly0descendants
- K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983128 | Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy… | Implex Corp. | 1998 | 1 |
| 0 (this device) | K051516 | Trabecular Metal Revision Shell Liners | Zimmer, Inc. | 2005 | — |
| +1 | K072121 | Trabecular Metal Acetabular Revision System Cemented Contrained Liner | Zimmer, Inc. | 2008 | — |
| +2 | K181366 | REDAPT Porous Acetabular Shell | Smith & Nephew, Inc. | 2018 | — |
| +1 | K253630 | Mpact 3D Metal Foam | Medacta International S.A. | 2026 | — |
| +1 | K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained… | Zimmer Biomet | 2025 | — |
| +3 | K242744 | Trinity EVO Acetabular Shell | Corin U.S.A. Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 2 | 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 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? (1)
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 |
|---|---|---|---|
| * | K983128 | Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy, 02-247-Xxyyy…Summary page 1…® Replacement Cup Insert, manufactured by Zimmer TMT (formerly known as Implex), K983128, cleared December 3, 1998. Device Description: This modified device is intended for cemented use… | 1998 |
What descends from it? (5)
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?
- Its one ancestor has a recall.
- Of its descendants, K072121 (Zimmer, Inc., 2008) has gone furthest, with 3 descendants of its own.
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.
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?
The TrabecularMetal Revision Shell Liner is indicated for cemented use in the TrabecularMetal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051516: Trabecular Metal Revision Shell Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051516
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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