# K051525: Arx Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Amedica Corp.
- Decided: Feb 17, 2006 after 254 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic Sofamor Danek Spinal Mesh: named in the summary without a submission number
- (no number) Synthes Vertebral Spacer System: named in the summary without a submission number
- (no number) Hedrocel Vertebral Body Replacement: named in the summary without a submission number
- (no number) Scient'x Ellys and Aurys VBR: named in the summary without a submission number
- (no number) DePuy Acromed VBR System: named in the summary without a submission number
- (no number) DePuy Acromed Surgical Titanium Mesh System: named in the summary without a submission number
- (no number) DePuy Acromed Stackable Cage System: named in the summary without a submission number
- (no number) EBI Ionic Spine Spacer System: named in the summary without a submission number
- (no number) Medtronic Sofamor Danek VERTE-STACK Spinal System: named in the summary without a submission number

## Most influential descendants
- K073125: Valeo VBR (2007), 1 descendant of its own
- K073505: Modification to Valeo VBR (2008), 0 descendants of its own

## Indications for use
The ARX Spinal System is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body. The ARX Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The ARX Spinal System is always to be used with supplemental internal spinal fixation. Additionally, the ARX Spinal System may be used with bone graft.

Source page: https://510kreport.com/device/K051525
Methodology: https://510kreport.com/methodology