# K991089: Synthes Cervifix System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: Aug 27, 1999 after 149 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.
678 later devices descend from it; 9 cite it directly.
2 of 679 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
The CerviFix 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 The CerviFix Plate/Rods are intended to provide stabilization to promote fusion of the cervical spine and occipitocervical junction (occiput - T3). The screws are limited to occipital fixation only. In addition, the CerviFix Rods are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The CerviFix System can also be linked to the Synthes Universal Spine System using the 3.5/6.0mm parallel connectors from that system.

Source page: https://510kreport.com/device/K991089
Methodology: https://510kreport.com/methodology