# K072434: Synthes OC Fusion and Synapse Systems

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine Co.Lp
- Decided: Jan 10, 2008 after 134 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K853033 (1985). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053418: Synthes OC Fusion System, Synthes Spine Co.Lp (2006) Summary page 1.
- K070573: Synapse System, Synthes Spine Co.Lp (2007) Summary page 3.

## Most influential descendants
- K090549: Synthes Synapse Transconnector (2009), 1 descendant of its own
- K181350: ASTRA-OCT Spine System (2018), 0 descendants of its own

## Indications for use
The 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 (C1-T3) that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes Synapse 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 spinal surgery a 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. Synthes Synapse System is indicated for the following: Hooks, Plate/Rods, Plates, Rods and Screws When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, OC Fusion and Synapse Systems are indicated for the following: * Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) * Spondylolisthesis * Spinal Stenosis * Fracture/dislocation * Atlantoaxial fracture with instability * Occipitocervical dislocation * Revision of pervious cervical spine surgery • Tumor When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only. Hooks and Rods The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1I-T3) spine. Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, and Transverse Bars The rods, clamps, screws, nuts, variable axis screws, locking screws, and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (TlI-T3). The use of these screws (3.5 mm, 4.0mmu and 4.5 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in TI 13 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine. The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 rmm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mm parallel connector. Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K072434
Methodology: https://510kreport.com/methodology