# K090549: Synthes Synapse Transconnector - Pathway: 510(k) (Special) - Applicant: Synthes Spine - Decided: May 21, 2009 after 80 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: 5 generations back to K853033 (1985). 9 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 11 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K072434: Synthes OC Fusion and Synapse Systems, Synthes Spine Co.Lp (2008) Summary page 1. - K070573: Synapse System, Synthes Spine Co.Lp (2007) Summary page 1. - K011969: Synthes Cervifix System, Synthes (Usa) (2001) ## Most influential descendants - K181350: ASTRA-OCT Spine System (2018), 0 descendants of its own ## Indications for use 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: ยท 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 (C1-T3) spine. Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, & 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 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. Source page: https://510kreport.com/device/K090549 Methodology: https://510kreport.com/methodology