# K981008: Simal Cervical Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Top Surgical Products GmbH
- Decided: May 27, 1998 after 70 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
Longest line of descent: 1 generation back to K792352 (1979). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953720: Aesculap Caspar Plate & Screw System for Anterior Cervical Fusion, Aesculap, Inc. (1995) Summary page 1.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995). Our OCR of the scanned summary read K845700, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes Anterior Cervical Vertebrate Plate System”.
- K792352: Synthes Cervical Vertabrae Plates, DePuy Synthes (1979) Summary page 1.

## Indications for use
The TSP Cervical Stabilization System is intended for anterior screw fixation to the cervical spine. Fixation is done via ventral or transoral approach. Spondylolisthesis (instability) Fractures Spinal Stenosis. Deformities (Scholiosis, Kyphosis, Lordosis) Tumors Pseudarthrosis

Source page: https://510kreport.com/device/K981008
Methodology: https://510kreport.com/methodology