# K092568: Spartan S3 Facet System

- Pathway: 510(k) (Traditional)
- Applicant: Amendia, Inc.
- Decided: Nov 17, 2009 after 89 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: 3 generations back to K953076 (1997). 8 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Most influential descendants
- K120340: Venus Facet Screw System (2012), 26 descendants of its own
- K163374: ALLY™ Facet Screws (2017), 18 descendants of its own
- K211855: Ion Facet Screw System (2022), 10 descendants of its own
- K230840: PMT Facet Fixation System, Lumbar (PMT FFS-LX) (2023), 9 descendants of its own
- K183589: PMT Facet Screw (2019), 8 descendants of its own

## 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 S1 (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/K092568
Methodology: https://510kreport.com/methodology