# K965221: Ransford Cervical Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Surgicraft, Ltd.
- Decided: Aug 7, 1997 after 219 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
Longest line of descent: 1 generation back to K853033 (1985). 1 ancestor in all.
694 later devices descend from it; 3 cite it directly.
2 of 696 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853033: Hartshill Rect & Wires, Spinal Fixation System, A.W. Showell (Surgicraft), Ltd. (1985) Summary page 3.

## Most influential descendants
- K982322: Synthes Spine Occipital-Cervical Plate/Rod and Hook System (1998), 692 descendants of its own
- 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

## Indications for use
1. Degenerative disk disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) spondylolisthesis of the cervical vertebrae Spinal stenosis of the cervical vertebrae Atlanto/axial fracture with instability Cervical-occipital dislocation Revision of previous cervical spine surgery Tumors

Source page: https://510kreport.com/device/K965221
Methodology: https://510kreport.com/methodology