# K070573: Synapse System

- Pathway: 510(k) (Special)
- Applicant: Synthes Spine Co.Lp
- Decided: Jun 8, 2007 after 100 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: 1 generation back to K023675 (2002). 2 ancestors in all.
378 later devices descend from it; 10 cite it directly.
2 of 381 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023675: Synthes Cervifix/ Axon, Synthes (Usa) (2002) Summary page 1.
- K030377: Modification to Synthes Cervifix System, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K100634: Synthes Matrix System (2010), 316 descendants of its own
- K100952: Modification to Synthes Matrix System (2010), 314 descendants of its own
- K124058: Creo Stabilization System (2013), 172 descendants of its own
- K143633: CREO Stabilization System (2015), 158 descendants of its own
- K111358: Synthes Uss (2011), 151 descendants of its own

## Indications for use
Synthes Synapse System is indicated for the following: Hooks, Plate/Rods, Rods and Screws When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, 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 (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 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/K070573
Methodology: https://510kreport.com/methodology