# K001864: Synthes Cervifix System

- Pathway: 510(k) (Special)
- Applicant: Synthes Spine
- Decided: Jul 20, 2000 after 30 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
733 later devices descend from it; 4 cite it directly.
3 of 734 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K001864
Methodology: https://510kreport.com/methodology