# K984377: Synthes Spine Cervifix System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 21, 1999 after 49 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; 4 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
The CerviFix System is intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction (occiput — T3) for the following indications: 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 occipital-cervical dislocation revision of previous cervical spine surgery tumors The screws are limited to occipital fixation only. The CerviFix System can also be linked to the Synthes Posterior Universal Spine System using the 3.5/6.0mm parallel connectors from that system.

Source page: https://510kreport.com/device/K984377
Methodology: https://510kreport.com/methodology