# K970599: Townley Pedicle Screw Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Danek Medical, Inc.
- Decided: Mar 20, 1998 after 395 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The TOWNLEY Pedicle Screw Plating System is intended to stabilize the spine as an aid to fusion. After first making drill holes in the pedicles, a DYNA-LOK® Plate is positioned over the pedicles. TOWNLEY Pedicle screws are then inserted through the DYNA-LOK plate, down the center of the pedicles, and into the vertebral body. Bone graft must be used with each procedure. This system is indicated for the treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: A. Trauma, including spinal fractures and/or dislocations. B. Spondylolisthesis. C. Spondylolysis. D. Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity. E. Degenerative disc disease and/or degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

Source page: https://510kreport.com/device/K970599
Methodology: https://510kreport.com/methodology