510(k) · Cleared
ClearedModification to 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 Aug 21, 2003 as substantially equivalent to K023882 (Implex Corp., 2003) after a 28-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Aug 21, 2003
- Review
- 28 days
- Class
- Class II
- Product code
- EZX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023882 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK023882 The Hedrocel Trabecular Metal Reconstruction SystemImplex Corp. · 2003
- This deviceK032282 Modification to Hedrocel Trabecular Metal Reconstruction SystemImplex Corp. · 2003
- Descendant · cites it directly · 0 of its ownK033384 The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZImplex Corp. · 2003
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −1 | K023882 | The Hedrocel Trabecular Metal Reconstruction System | Implex Corp. | 2003 | — |
| 0 (this device) | K032282 | Modification to Hedrocel Trabecular Metal Reconstruction System | Implex Corp. | 2003 | — |
| +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 | 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? (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 |
|---|---|---|---|
| * | 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 023882. In addition, mechanical test data found in MAF #920 indicate the Hedrocel porous tantalum possesses… | 2003 |
| † | K010378 | Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033384 | The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ | 2003 | 0 |
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?
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/K032282 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032282: Modification to Hedrocel Trabecular Metal Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032282
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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