# K053418: Synthes OC Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine Co.Lp
- Decided: Sep 6, 2006 after 272 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K853033 (1985). 3 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982322: Synthes Spine Occipital-Cervical Plate/Rod and Hook System, Synthes (Usa) (1998) Summary page 1.

## Most influential descendants
- K083863: Theken Atoll Oct Spinal System (2009), 21 descendants of its own
- K141222: Nautilus Spinal System and Solstice Oct System (2015), 13 descendants of its own
- K151196: Nautilus Spinal System (2015), 12 descendants of its own
- K191575: ARx Spinal System (2019), 10 descendants of its own
- K200070: ARx Spinal System (2020), 9 descendants of its own

## Indications for use
Synthes OC Fusion System is intended to provide stabilization to promote fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (CI-T3) that have been previously cleared within the Synthes CerviFix System and the Synthes Axon System. Synthes OC Fusion System is indicated for the following: * Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) * Spondylolisthesis * Spinal Stenosis * Fracture/Dislocation * Atlanto/axial fracture with instability * Occipital-cervical dislocation * Revision of previous cervical spine surgery * Tumors (primary and metastatic) The use of screws is limited to placement in the occiput. Screws are not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K053418
Methodology: https://510kreport.com/methodology