# K051781: Graftcage TLX

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Dec 16, 2005 after 168 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003155 (2001). 19 ancestors in all.
No later device cites it as a predicate yet.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011037: Vertebral Spacer, Synthes (Usa) (2002)
- K010530: Geo Structure, Interpore Cross Intl. (2001) Summary page 1.
- K042571: Stryker Spine Avs TL Peek Spacer, Stryker Spine (2005) Summary page 1.

## Recalls of this device
- May 22, 2012 · Class I · Z-1931-2012: Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative result

## Indications for use
The GraftCageTM TLX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (TI -L5). The Graftcage TLX is indicated for a partial or total vertebrectomy for cases of tumor or trauma (i.e., fracture). The GraftCage TLX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body. The GraftCage TLX is intended for use with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. These systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems. The use of bone grafting material with the GraftCage TLX is optional.

Source page: https://510kreport.com/device/K051781
Methodology: https://510kreport.com/methodology