# K110170: Raptor Facet Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Nov 28, 2011 after 312 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: 5 generations back to K020411 (2002). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092464: Spineology Facet Screw, Spineology, Inc. (2009) Summary page 2.
- K090767: Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer, Interventional Spine, Inc. (2009) Summary page 2.
- K102438: Primalok Facet Fixation System, Osteomed LP (2010) Summary page 2.
- K100154: Fixcet Spinal Facet Screw System, X-Spine Systems, Inc. (2010) Summary page 2.
- K071420: Chameleon Fixation System, Spinefrontier, Inc. (2008) Summary page 2.

## Indications for use
The Raptor Tm Facet Fixation System 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. Raptor Tm Facet Fixation System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from Li-Si inclusive. The Raptor Tm Facet Fixation System is indicated for treatment of any or all of the following: - degenerative disc disease (ODD) as defined by back pain of discogenic origins confirmed by history and radiographic studies - degenerative disease of the facets with instability - trauma (i.e. fracture or dislocation) - spondylolisthesis - spondylolysis - pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity

Source page: https://510kreport.com/device/K110170
Methodology: https://510kreport.com/methodology