# K980358: Synthes Spine Posterior Cervical/Thoracic Hook/Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 16, 1998 after 77 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 K850039 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850039: Halifax Spinal Clamp, Levtech, Inc. (1985). Our OCR of the scanned summary read K850030, FDA’s number for Concentrical Continuous Passive Motion Machine (Arc Motion, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AME Halifax Interlaminar Clamp System”.
- K962314: Halifax Plus Interlaminar Clamp System, Osteonics Corp. (1996). Our OCR of the scanned summary read K062314, FDA’s number for Horus Laser Keratome (Carl Zeiss Meditec, AG), decided Dec 22, 2006, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AME Halifax Interlaminar Clamp System”.

## Indications for use
The Posterior Cervical/Thoracic Hook/Rod System is intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Source page: https://510kreport.com/device/K980358
Methodology: https://510kreport.com/methodology