510(k) · Cleared
ClearedThe Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implex Corp. · JDK Prosthesis, Hip, Cement Restrictor
Cleared on Nov 19, 2003 as substantially equivalent to K023882 (Implex Corp., 2003) and 2 other predicates after a 27-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Nov 19, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- JDK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K023882 (2003). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK023882 The Hedrocel Trabecular Metal Reconstruction SystemImplex Corp. · 2003
- 1 generation backK032282 Modification to Hedrocel Trabecular Metal Reconstruction SystemImplex Corp. · 2003
- This deviceK033384 The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZImplex Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023882 | The Hedrocel Trabecular Metal Reconstruction System | Implex Corp. | 2003 | — |
| −1 | K032282 | Modification to Hedrocel Trabecular Metal Reconstruction System | Implex Corp. | 2003 | — |
| 0 (this device) | K033384 | The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ | Implex Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 JDK? 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 JDK device
- #1 K210062 Mectaplug PE IIscore 5.1 · 14 generations · no Class I recall
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 |
|---|---|---|---|
| * | K023882 | The Hedrocel Trabecular Metal Reconstruction SystemSummary page 2…Reconstructive System was tested per Data: FDA guidance documents and applicable standards for KO10378, as referenced in the predicate K023882, KO32282 and K032344. In addition, mechanical test data found in MAF #920 and K962468, and… | 2003 |
| * | K032282 | Modification to Hedrocel Trabecular Metal Reconstruction System | 2003 |
| * | K032344 | The Hedrocel Trabecular Metal Reconstruction System Model 10-330Summary page 2…m was tested per Data: FDA guidance documents and applicable standards for KO10378, as referenced in the predicate K023882, KO32282 and K032344. In addition, mechanical test data found in MAF #920 and K962468, and calculations found… | 2003 |
| † | K010378 | Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ | 2002 |
| † | K962468 | Hedrocel Acetabular Restrictor | 1997 |
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 0 years and passes through 1 company; a new generation was cleared every 6 months on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K023882.
How does its category compare?
All JDK devicesJDK Prosthesis, Hip, Cement Restrictor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDK
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JDK
Too few JDK 510(k)s in any year since 2007 to give a median.
Recalls per year · JDK
5in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDK
6in 2025
MAUDE reports naming product code JDK, 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 | 0 | — | 6 | 3 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 5 | 3 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel Trabecular Metal Reconstruction System may also be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033384 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033384: The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033384
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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