# K010378: Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Jan 28, 2002 after 354 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.
28 later devices descend from it; 8 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021025: Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ (2002), 26 descendants of its own
- 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

Source page: https://510kreport.com/device/K010378
Methodology: https://510kreport.com/methodology