# K991662: Titanium Hartshill System

- Pathway: 510(k) (Traditional)
- Applicant: Surgicraft, Ltd.
- Decided: Nov 8, 1999 after 178 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.
No later device cites it as a predicate yet.
0 of 2 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 2.

## Indications for use
Surgical stabilization and fusion of the cervical spine for the correction of spinal deficiencies. Spinal deformity Spinal tumors Spinal fracture Dislocations Subluxations Spondylolisthesis

Source page: https://510kreport.com/device/K991662
Methodology: https://510kreport.com/methodology