# K032812: Endoskeleton TA Vertebral Body Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita, Inc.
- Decided: Dec 8, 2003 after 90 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003275 (2001). 7 ancestors in all.
565 later devices descend from it; 4 cite it directly.
1 of 573 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K013382: Modification to: Stackable Cage System, Depuyacromed (2001) Summary page 1.
- K020152: Synthes Vertebral Spacer TI, Synthes (Usa) (2002) Summary page 1.
- K024364: Synthes Vertebral Spacer TI (Curved and Narrow), Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K080615: Endoskeleton TA Interbody Fusion Device (Ibd) (2008), 564 descendants of its own
- K101310: VU Apod Intervertebral Body Fusion Device (2010), 480 descendants of its own
- K133286: Midline (TM) (2014), 460 descendants of its own
- K141942: Midline II TI (2014), 459 descendants of its own
- K083714: Endoskeleton TT Interbody Fusion Device (Ibd) (2009), 412 descendants of its own

## Recalls of this device
- Oct 19, 2012 · Class II · Z-0535-2013: Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.

## Indications for use
The Endoskeleton TA VBR is for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Endoskeleton TA VBR is intended for use with supplemental internal spinal fixation systems. The Endoskeleton TA VBR may be used with bone graft material or bone graft substitute.

Source page: https://510kreport.com/device/K032812
Methodology: https://510kreport.com/methodology