# K994308: Nuvasive Townley Facet Screw

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Apr 18, 2000 after 119 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
159 later devices descend from it; 3 cite it directly.
0 of 160 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 Bone Graft Screw (also known as the Townley Compression Screw): named in the summary without a submission number

## Most influential descendants
- K012773: Discovery Facet Screw Fixation System (2001), 158 descendants of its own
- K071420: Chameleon Fixation System (2008), 153 descendants of its own
- K131417: Facet Fixx (2013), 130 descendants of its own
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own
- K181435: ATEC Cervical Spacer System (2018), 100 descendants of its own

## Indications for use
The Townley Tranfacet/Intrapedicular Screw is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The Townley Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, and from C2 to S1, for treatment of any or all of the following: (a) pseudoarthrosis and failed previous fusion, (b) spondylolisthesis, (c) spondylolysis; (d) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, (e) degeneration of the facets with instability; and (f) fracture

Source page: https://510kreport.com/device/K994308
Methodology: https://510kreport.com/methodology