510(k) · Cleared
ClearedThe Hedrocel Trabecular Metal Reconstruction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implex Corp. · EZX Mesh, Surgical, Metal
Cleared on Feb 19, 2003 after a 90-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Feb 19, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- EZX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK023882 The Hedrocel Trabecular Metal Reconstruction SystemImplex Corp. · 2003
- Descendant · cites it directly · 2 of its ownK032344 The Hedrocel Trabecular Metal Reconstruction System Model 10-330Implex Corp. · 2003
- Descendant · cites it directly · 1 of its ownK032282 Modification to Hedrocel Trabecular Metal Reconstruction SystemImplex Corp. · 2003
- Descendant · 2 generations on · 0 of its ownK040756 The Trabecular Metal Reconstruction System, Model 10-340-XxxxxImplex Corp. · 2004
- Descendant · cites it directly · 0 of its ownK033384 The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZImplex Corp. · 2003
Most influential descendants
Showing 4 of 4 · See all- K032344The Hedrocel Trabecular Metal Reconstruction System Model 10-330Implex Corp. · 2003 · cites it directly2descendants
- K032282Modification to Hedrocel Trabecular Metal Reconstruction SystemImplex Corp. · 2003 · cites it directly1descendant
- K040756The Trabecular Metal Reconstruction System, Model 10-340-XxxxxImplex Corp. · 2004 · 2 generations on0descendants
- K033384The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZImplex Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023882 | The Hedrocel Trabecular Metal Reconstruction System | Implex Corp. | 2003 | — |
| +1 | K032344 | The Hedrocel Trabecular Metal Reconstruction System Model 10-330 | Implex Corp. | 2003 | — |
| +1 | K032282 | Modification to Hedrocel Trabecular Metal Reconstruction System | Implex Corp. | 2003 | — |
| +2 | K040756 | The Trabecular Metal Reconstruction System, Model 10-340-Xxxxx | Implex Corp. | 2004 | — |
| +1 | K033384 | The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ | Implex Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 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 EZX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
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?
- Of its descendants, K032344 (Implex Corp., 2003) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EZX devicesEZX Mesh, Surgical, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZX
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · EZX
Too few EZX 510(k)s in any year since 2007 to give a median.
Recalls per year · EZX
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZX
1in 2025
MAUDE reports naming product code EZX, 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 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 0 | — | 0 | 35 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 1 |
| 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/K023882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023882: The Hedrocel Trabecular Metal Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023882
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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