# K051978: Trabecular Metal Vertebral Body Replacement

- Pathway: 510(k) (Special)
- Applicant: Implex Corp.
- Decided: Sep 23, 2005 after 64 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: 5 generations back to K003709 (2001). 8 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 31 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 1.
- K021025: Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ, Implex Corp. (2002) Summary page 1.
- K021967: Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and 06-132-10XX2, Implex Corp. (2002) Summary page 1.
- K022563: Hydrocel Vertebral Body Replacement, Model 06-172-00XX1, Implex Corp. (2002) Summary page 1.
- K031823: Hedrocel Vertebral Body Replacement, Model 06-172-00XX1, Implex Corp. (2003) Summary page 1.
- K032527: Hedrocel Vertebral Body Replacement, Implex Corp. (2003) Summary page 1.
- K051196: Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1, Implex Corp. (2005) Summary page 1.

## Most influential descendants
- 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
- K162986: SPIRA Open Matrix ALIF (2017), 11 descendants of its own
- K180724: SPIRA Open Matrix LLIF (2018), 10 descendants of its own

## Indications for use
The Trabecular Metal 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 Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.

Source page: https://510kreport.com/device/K051978
Methodology: https://510kreport.com/methodology