510(k) · Cleared
ClearedCross Linked Polyethylene Acetabular Components,Model XX-YY-Zzzzzz
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 Mar 1, 2000 after a 393-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 1, 2000
- Review
- 393 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (6)
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 HEP (Hedrocel) Acetabular Cup Named without a submission number | |
| * | — | Implex Revision HEP (Hedrocel) Acetabular Cup Named without a submission number | |
| * | — | Implex A-230 Acetabular Cup System Named without a submission number | |
| * | — | Implex Modular Elliptical Porous Cup System Named without a submission number | |
| * | — | DePuy Duraloc Acetabular Cup System Named without a submission number | |
| * | — | Osteonics Cross-Fire Acetabular Components Named without a submission number |
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.
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 Cross-Linked Polysthylene Acetabular Components are intended to be used with the below listed, legally marketed Implex Acetabular Component Replacement Systems to resurface the acetabular socket in cemented or cementless total hip arthroplasty. Implex Cross-Linked Polysthylene Acetabular Components are for use with the following legally marketed Implex devices with 28 mm femoral heads: 1. The Implex HEP (Hedrocel) Acetabular Cup, cemented &…
Read the full statement (185 words)
The Implex Cross-Linked Polysthylene Acetabular Components are intended to be used with the below listed, legally marketed Implex Acetabular Component Replacement Systems to resurface the acetabular socket in cemented or cementless total hip arthroplasty.
Implex Cross-Linked Polysthylene Acetabular Components are for use with the following legally marketed Implex devices with 28 mm femoral heads:
1. The Implex HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
2. The Implex Revision HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
3. The Implex A-230 (porous beads) Acetabular Cup System, cemented & cementless. The permitted OD size is 52 mm and greater for the 0°, 10 ° and 20° face angle options.
4. The Implex Modular Elliptical Porous Cup. The permitted OD size is 54 mm and greater for the 0°, 10° and 20° face angle options.
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/K990330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990330: Cross Linked Polyethylene Acetabular Components,Model XX-YY-Zzzzzz.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990330
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026