# K113011: Spartan S3 Facet System

- Pathway: 510(k) (Special)
- Applicant: Amendia, Inc.
- Decided: Dec 6, 2011 after 56 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: 4 generations back to K953076 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092568: Spartan S3 Facet System, Amendia, Inc. (2009) Summary page 1.
- K101364: Lanx Facet Screw System, Lanx, Inc. (2010)
- K012773: Discovery Facet Screw Fixation System, Depuyacromed (2001) Summary page 1.
- K020411: Nuvasive Triad Facet Screw System, Nuvasive, Inc. (2002) Summary page 1.
- K031657: Stryker Spine Oasys Bone Screw, Howmedica Osteonics Corp. (2003) Summary page 1.
- K073515: TRANS1 Facet Screw, Trans1 Incorporated (2008) Summary page 1.

## Indications for use
The Spartan S3 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to SI (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 4) 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. The Spartan S3 Facet System will provide temporary stabilization as an adjunct to spinal fusion.

Source page: https://510kreport.com/device/K113011
Methodology: https://510kreport.com/methodology