# K990965: Synthes Cervifix System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 1, 1999 after 101 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
No predicates in its family tree.
672 later devices descend from it; 3 cite it directly.
2 of 673 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
- K002733: Summit Occipito-Cervico-Thoracic (Oct) Spinal System (2000), 671 descendants of its own
- K013222: Summit Occipito-Cervico- Thoracic (Oct) Spinal System (2001), 660 descendants of its own
- K022190: Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System (2002), 659 descendants of its own
- K030103: Summit Oct Spinal System Minipolyaxial Screws (2003), 658 descendants of its own
- K041203: Summit Oct Spinal System (2004), 657 descendants of its own

## Indications for use
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 (3.2mm cortex, 3.5mm and 4.0mm cancellous) components of the Synthes CerviFix System are 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 atlanto axial 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 (C1-T3) spine. Rods, Clamps and Screws The rods, clamps and screws are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3) The use of these screws (3.5mm cancellous, 4.0mm cancellous, 4.0mm and 4.35 expansionhead) 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 CerviFix System can also be linked to the Synthes Universal Spinal System using the 3.5/6.0mm parallel connectors from that system.

Source page: https://510kreport.com/device/K990965
Methodology: https://510kreport.com/methodology