# K982322: Synthes Spine Occipital-Cervical Plate/Rod and Hook System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 25, 1998 after 146 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: 2 generations back to K853033 (1985). 2 ancestors in all.
692 later devices descend from it; 4 cite it directly.
2 of 695 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965221: Ransford Cervical Fixation System, Surgicraft, Ltd. (1997). Our OCR of the scanned summary read K965227, FDA’s number for Osom Classic HCG-Urine Test (115) (Wyntek Diagnostics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ransford Cervical Fixation System”. Summary page 1.

## 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 Synthes Spine Occipital-Cervical Plate/Rod and Hook System is intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction (occiput — T3) for the following indications: . Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) o Spondylolisthesis of the cervical vertebrae . Spinal stenosis of the cervical vertebrae . Atlanto-axial fracture with instability . Occipital-cervical dislocation . Revision of cervical spine fusion surgeries . Tumors

Source page: https://510kreport.com/device/K982322
Methodology: https://510kreport.com/methodology