# K053080: Graftcage Acx

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Dec 1, 2005 after 29 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: 6 generations back to K841189 (1984). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012254: VBR, Osteotech, Inc. (2001) Summary page 2.
- K030833: Depuy Acromed VBR System, Depuyacromed (2003) Summary page 2.
- K031635: Depuy Acromed VBR System, Depuyacromed (2003) Summary page 2.
- K010378: Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ, Implex Corp. (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K051000: Fortitude Vue Vertebral Body Replacement Device, Spinal Concepts, Inc. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The GraftCage TM ACX 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 GraftCageTM ACX is indicated for a partial or total vertebrectormy for cases of tumor or trauma (i.e., fracture). The GraftCage TM ACX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body. The GraftCageTM ACX 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' TM ACX is optional.

Source page: https://510kreport.com/device/K053080
Methodology: https://510kreport.com/methodology