# K022563: Hydrocel Vertebral Body Replacement, Model 06-172-00XX1

- Pathway: 510(k) (Special)
- Applicant: Implex Corp.
- Decided: Aug 30, 2002 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
Longest line of descent: 3 generations back to K003709 (2001). 4 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010378: Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ, Implex Corp. (2002)
- K021025: Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ, Implex Corp. (2002)
- K021967: Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and 06-132-10XX2, Implex Corp. (2002)

## 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 (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocep Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocep Vertebral Body Replacement may be used with bone graft.

Source page: https://510kreport.com/device/K022563
Methodology: https://510kreport.com/methodology