510(k) · Cleared
Recalled · Class II · 2016Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy, 02-247-Xxyyy, 02-248-Xxyyy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implex Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Dec 3, 1998 after an 86-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled once.
- Decided
- Dec 3, 1998
- Review
- 86 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK983128 Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy…Implex Corp. · 1998
- Descendant · cites it directly · 5 of its ownK051516 Trabecular Metal Revision Shell LinersZimmer, Inc. · 2005
- Descendant · 2 generations on · 3 of its ownK072121 Trabecular Metal Acetabular Revision System Cemented Contrained LinerZimmer, Inc. · 2008
- Descendant · 3 generations on · 1 of its ownK181366 REDAPT Porous Acetabular ShellSmith & Nephew, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK253630 Mpact 3D Metal FoamMedacta International S.A. · 2026
- Descendant · 2 generations on · 0 of its ownK243571 Trabecular Metal Acetabular Revision System, Acetabular Liners and…Zimmer Biomet · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K051516Trabecular Metal Revision Shell LinersZimmer, Inc. · 2005 · cites it directly5descendants
- K072121Trabecular Metal Acetabular Revision System Cemented Contrained LinerZimmer, Inc. · 2008 · 2 generations on3descendants
- K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc. · 2018 · 3 generations on1descendant
- K253630Mpact 3D Metal FoamMedacta International S.A. · 2026 · 2 generations on0descendants
- K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983128 | Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy… | Implex Corp. | 1998 | — |
| +1 | K051516 | Trabecular Metal Revision Shell Liners | Zimmer, Inc. | 2005 | — |
| +2 | K072121 | Trabecular Metal Acetabular Revision System Cemented Contrained Liner | Zimmer, Inc. | 2008 | — |
| +3 | K181366 | REDAPT Porous Acetabular Shell | Smith & Nephew, Inc. | 2018 | — |
| +2 | K253630 | Mpact 3D Metal Foam | Medacta International S.A. | 2026 | — |
| +2 | K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained… | Zimmer Biomet | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Implex Hedrocel® Porous Acetabular Cup System Named without a submission number | |
| * | — | Implex Replacement Acetabular Cup Insert System Named without a submission number | |
| * | — | Osteonics GAP II Restoration Acetabular shell with Omnifit® Polyethylene Insert Bearing Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051516 | Trabecular Metal Revision Shell Liners | 2005 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 15, 2016 | Class II | Z-1954-2016 | Unknown/Undetermined by firm | Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051516 (Zimmer, Inc., 2005) has gone furthest, with 5 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 Implex Hedrocel® Replacement Cup Insert, cemented, is intended for use as an in-situ replacement polyethylene bearing surface under circumstances of joint instability, wear and/or damage caused by the patient during use.
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/K983128 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983128: Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy, 02-247-Xxyyy, 02-248-Xxyyy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983128
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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