# K031823: Hedrocel Vertebral Body Replacement, Model 06-172-00XX1

- Pathway: 510(k) (Special)
- Applicant: Implex Corp.
- Decided: Jul 11, 2003 after 28 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K051196: Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1 (2005), 23 descendants of its own
- K051978: Trabecular Metal Vertebral Body Replacement (2005), 22 descendants of its own
- K052950: The Zimmer TMT Trabecular Metal Vertebral Body Replacement System (2005), 21 descendants of its own
- K120203: TM-400 Device (2012), 20 descendants of its own
- K143297: Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) (2015), 19 descendants of its own

## Indications for use
The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI -- 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.

Source page: https://510kreport.com/device/K031823
Methodology: https://510kreport.com/methodology