# K080020: Arcofix

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine Co.Lp
- Decided: May 23, 2008 after 141 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- 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: 1 generation back to K022791 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022791: Synthes Anterior Tension Band (Atb) System, Synthes (Usa) (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K031100: Synthes Ventrofix Mis System, Synthes (Usa) (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Synthes ArcoFix System is indicated for use, via the lateral or anterolateral surgical approach, in the treatment of thoracic and thoracolumbar (T 1-L5) spine instability as a result of the following: * Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) * Spondylolisthesis * Spondylolysis * Fracture (including dislocation and subluxation) * Spinal stenosis * Deformities (i.e. scoliosis, kyphosis, lordosis whether neuromuscular or related to deficient posterior elements) * Tumors (neoplastic disease) * Pseudoarthrosis * Failed previous fusion.

Source page: https://510kreport.com/device/K080020
Methodology: https://510kreport.com/methodology