510(k) · Cleared

Cleared

The Hedrocel Trabecular Metal Reconstruction System Model 10-330

K032344510(k) SpecialCleared Oct 2, 200364-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Implex Corp. · EZX Mesh, Surgical, Metal

Cleared on Oct 2, 2003 as substantially equivalent to K023882 (Implex Corp., 2003) after a 64-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.

Decided: Oct 2, 2003
Review: 64 days
Class: Class II
Product code: EZX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K023882 (2003). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK023882 The Hedrocel Trabecular Metal Reconstruction SystemImplex Corp. · 2003
This deviceK032344 The Hedrocel Trabecular Metal Reconstruction System Model 10-330Implex Corp. · 2003
Descendant · cites it directly · 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 2 of 2 · See all

K040756The Trabecular Metal Reconstruction System, Model 10-340-XxxxxImplex Corp. · 2004 · cites it directly0descendants
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)	K032344	The Hedrocel Trabecular Metal Reconstruction System Model 10-330	Implex Corp.	2003	—
+1	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	1	0
2004	1	0

FIG. 1 — Lineage of K032344, 2003–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K023882	The Hedrocel Trabecular Metal Reconstruction System	Implex Corp.	2003	—
†	K962468	Hedrocel Acetabular Restrictor	Implex Corp.	1997	—

Also cleared against K023882: 2 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040756	The Trabecular Metal Reconstruction System, Model 10-340-Xxxxx	Implex Corp.	2004	0
K033384	The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ	Implex Corp.	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?

Its one ancestor has no recall.
Of its descendants, K040756 (Implex Corp., 2004) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K023882.

How does its category compare?

All EZX devices

EZX Mesh, Surgical, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EZX

1in 2009

2007high 1 (2009) · low 0 (2007)2026

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

2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EZX

1in 2025

2007high 35 (2021) · low 1 (2025)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 be used with bone graft.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032344 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032344: The Hedrocel Trabecular Metal Reconstruction System Model 10-330.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032344

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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