# K012773: Discovery Facet Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Depuyacromed
- Decided: Nov 16, 2001 after 88 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
Longest line of descent: 1 generation back to K994308 (2000). 2 ancestors in all.
158 later devices descend from it; 14 cite it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003928: Townley Transfacetpedicular Screw Fixation System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K994308: Nuvasive Townley Facet Screw, Nuvasive, Inc. (2000). Our OCR of the scanned summary read K984308, 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, “Townley Transfacet/Intrapedicular Screw”.
- (no number) Preamendment Townley Bone Graft Screw: named in the summary without a submission number

## Most influential descendants
- 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
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own

## Indications for use
The Discovery Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods: Transfacet fixation - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle. Translaminar-facet fixation - The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet across the facet joint and into the inferior pedicle. For both methods, this system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) 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/K012773
Methodology: https://510kreport.com/methodology