# K030377: Modification to Synthes Cervifix System

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Mar 6, 2003 after 29 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
No predicates in its family tree.
391 later devices descend from it; 5 cite it directly.
2 of 392 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070573: Synapse System (2007), 378 descendants of its own
- 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

## Indications for use
The CerviFixO System is indicated for the following: DDD (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 Tumors When used to treat these cervical and occipitocervical conditions, these 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 (Cl-T3) spine. Rods, Clamps, Screws and Nuts The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/disIocation or trauma in the upper thoracic spine (TI -T3). The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in TI-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine. The Synthes CewiFixTMSystem can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.O 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.

Source page: https://510kreport.com/device/K030377
Methodology: https://510kreport.com/methodology