510(k) Report

510(k) · Cleared

Cleared

Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ

K021025510(k) SpecialCleared May 20, 200252-day reviewClass II21 CFR 888.3060

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

Implex Corp. · MQP Spinal Vertebral Body Replacement Device

Cleared on May 20, 2002 as substantially equivalent to K010378 (Implex Corp., 2002) and 1 other predicate after a 52-day review. Its family tree reaches back 1 generation to 2001. 26 later devices descend from it.

Decided
May 20, 2002
Review
52 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K003709 (2001). 2 ancestors in all. 26 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2005: 3 descendants cleared2002: 2 descendants cleared2012: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2017: 2 descendants cleared2019: 1 descendant cleared2018: 1 descendant cleared2024: 3 descendants cleared2022: 2 descendants cleared2021: 2 descendants cleared2020: 1 descendant cleared2026: 2 descendants cleared2025: 3 descendants cleared2023: 1 descendant clearedK003709 · Surgical Dynamics Mesh Cage System · United States Surgical, A Division of Tyco Healthc · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 3 descendants6 generations forward: 5 descendants7 generations forward: 6 descendants8 generations forward: 5 descendants K003709 · Surgical Dynamics Mesh Cage System · United States Surgical, A Division of Tyco Healthc · 20010+5
  1. Root · 1 generation backK003709 Surgical Dynamics Mesh Cage SystemUnited States Surgical, A Division of Tyco Healthc · 2001
  2. This deviceK021025 Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZImplex Corp. · 2002
  3. Descendant · cites it directly · 25 of its ownK021967 Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and…Implex Corp. · 2002
  4. Descendant · cites it directly · 24 of its ownK022563 Hydrocel Vertebral Body Replacement, Model 06-172-00XX1Implex Corp. · 2002
  5. Descendant · cites it directly · 23 of its ownK051196 Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and…Implex Corp. · 2005
  6. Descendant · cites it directly · 22 of its ownK051978 Trabecular Metal Vertebral Body ReplacementImplex Corp. · 2005
  7. Descendant · 2 generations on · 21 of its ownK052950 The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemZimmer Trabecular · 2005

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2002: 22005: 32012: 12015: 12016: 12017: 22018: 12019: 12020: 12021: 22022: 22023: 12024: 32025: 32026: 2
2002high 3 (2005) · low 0 (2003)2026

Most influential descendants

Showing 5 of 26 · See all
  • K021967Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and 06-132-10XX2Implex Corp. · 2002 · cites it directly25descendants
  • K022563Hydrocel Vertebral Body Replacement, Model 06-172-00XX1Implex Corp. · 2002 · cites it directly24descendants
  • K051196Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1Implex Corp. · 2005 · cites it directly23descendants
  • K051978Trabecular Metal Vertebral Body ReplacementImplex Corp. · 2005 · cites it directly22descendants
  • K052950The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemZimmer Trabecular · 2005 · 2 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003709Surgical Dynamics Mesh Cage SystemUnited States Surgical, A Division of Tyco Healthc2001—
0 (this device)K021025Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZImplex Corp.2002—
+1K021967Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and 06-132-10XX2Implex Corp.2002—
+1K022563Hydrocel Vertebral Body Replacement, Model 06-172-00XX1Implex Corp.2002—
+1K051196Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1Implex Corp.2005—
+1K051978Trabecular Metal Vertebral Body ReplacementImplex Corp.2005—
+2K052950The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemZimmer Trabecular2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200530
201210
201510
201610
201720
201810
201910
202010
202120
202220
202310
202430
202530
202620
FIG. 1 — Lineage of K021025, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MQP? 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 MQP device

  1. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K010378Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ
Summary page 2
…ebral Body Replacement System is substantially equivalent to the following predicate devices identified in this premarket notification: 510(k) # | Product Name Company K010378 | Hedrocel Vertebral Body Replacement Implex K003709 | Surgical Dynamics (SDI) Mesh Cage United States Surgical System March 20,…
Implex Corp.2002—
*K003709Surgical Dynamics Mesh Cage System
Summary page 2
…lent to the following predicate devices identified in this premarket notification: 510(k) # | Product Name Company K010378 | Hedrocel Vertebral Body Replacement Implex K003709 | Surgical Dynamics (SDI) Mesh Cage United States Surgical System March 20, 2002 49 DEPARTMENT OF HEALTH & HUMAN…
United States Surgical, A Division of Tyco Healthc2001—

Also cleared against K010378: 7 other devices →

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K021967Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and 06-132-10XX2Implex Corp.200225
K022563Hydrocel Vertebral Body Replacement, Model 06-172-00XX1Implex Corp.200224
K051196Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1Implex Corp.200523
K051978Trabecular Metal Vertebral Body ReplacementImplex Corp.200522

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K021967 (Implex Corp., 2002) has gone furthest, with 25 descendants of its own.
  • 7 other devices also cite its predicate K010378.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

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

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 — L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K010378

7 other devices cite the same predicate.

  • K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc. · 2012
  • K053080Graftcage AcxOsteotech, Inc. · 2005
  • K052950The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemZimmer Trabecular · 2005
  • K051978Trabecular Metal Vertebral Body ReplacementImplex Corp. · 2005
  • K051196Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1Implex Corp. · 2005
  • K022563Hydrocel Vertebral Body Replacement, Model 06-172-00XX1Implex Corp. · 2002

More from Implex Corp.

65 FDA decisions under this applicant name. See the company

  • K051978Trabecular Metal Vertebral Body ReplacementImplex Corp. · 2005
  • K051196Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1Implex Corp. · 2005
  • K040487Trabecular Metal Knee System AugmentsImplex Corp. · 20041 recall
  • K040630Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZImplex Corp. · 20042 recalls
  • K040756The Trabecular Metal Reconstruction System, Model 10-340-XxxxxImplex Corp. · 2004

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K021025 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021025: Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021025

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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