# K141897: Synapse System, Synthes OC Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA Products, LLC
- Decided: Sep 25, 2014 after 73 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: 12 generations back to K853033 (1985). 38 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133698: Synapse System, Synthes USA Products, LLC (2014) Summary page 6.
- K091689: Synapse System 4.0MM, OC Fusion System 4.0MM, Synthes (Usa) (2009) Summary page 6.
- K023675: Synthes Cervifix/ Axon, Synthes (Usa) (2002) Summary page 6.
- K030377: Modification to Synthes Cervifix System, Synthes (Usa) (2003) Summary page 6.

## Most influential descendants
- K142867: Reliance Posterior Cervical-Thoracic System (2015), 3 descendants of its own
- K213394: Vy Spine™ VySpan™ PCT System (2021), 2 descendants of its own
- K223852: VySpan™ PCT System (2023), 1 descendant of its own
- K232167: VySpan™ PCT System (2023), 0 descendants of its own
- K181350: ASTRA-OCT Spine System (2018), 0 descendants of its own

## Indications for use
These Systems are intended for the following: Hooks, Plate/Rods, Plates, Rods and Screws When intended to provide stabilization as an adjunct to 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 skeletally mature patients using allograft and/or autograft 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 previous 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 (C1-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 (T1-T3). The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 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 mm/6.0 mm and 4.0 mm/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 (T4-T12), or lumbar spine. The Synthes OC Fusion System is intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) and screws (T1-T3) that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes Synapse System. The OC Fusion System is indicated for skeletally mature patients using allograft and/or autograft for the following indications: • 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 into the cervical spine.

Source page: https://510kreport.com/device/K141897
Methodology: https://510kreport.com/methodology