# K021025: Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ

- Pathway: 510(k) (Special)
- Applicant: Implex Corp.
- Decided: May 20, 2002 after 52 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: 1 generation back to K003709 (2001). 2 ancestors in all.
26 later devices descend from it; 4 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) Summary page 2.
- K003709: Surgical Dynamics Mesh Cage System, United States Surgical, A Division of Tyco Healthc (2001) Summary page 2.

## Most influential descendants
- K021967: Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and 06-132-10XX2 (2002), 25 descendants of its own
- K022563: Hydrocel Vertebral Body Replacement, Model 06-172-00XX1 (2002), 24 descendants of its own
- 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

## 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 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/K021025
Methodology: https://510kreport.com/methodology