# K983706: Modification of Townley Pedicle Screw Plating System

- Pathway: 510(k) (Special)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Nov 12, 1998 after 22 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
No predicates in its family tree.
19 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TOWNLEY Pedicle Screw Plating System: named in the summary without a submission number

## Most influential descendants
- K031354: Ebi OMEGA21 Spinal Fixation System (2003), 13 descendants of its own
- K082353: Mercury Spinal System (2009), 11 descendants of its own
- K083230: Mercury Spinal System (2008), 11 descendants of its own
- K091587: Mercury Spinal System (2009), 10 descendants of its own
- K141372: Mercury Spinal System (2014), 9 descendants of its own

## 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 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, all grades and types, (c) Spondylolysis, (d) Pseudarthrosis, (e) Degenerative disc disease and/or degenerative diseases which include: (1) 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 (2) degenerative disease of the facets with instability. For all these indications, bone graft must be used and the system is limited to screw fixation from C2 to S1.

Source page: https://510kreport.com/device/K983706
Methodology: https://510kreport.com/methodology