# K163374: ALLY™ Facet Screws

- Pathway: 510(k) (Traditional)
- Applicant: Providence Medical Technology, Inc.
- Decided: Feb 16, 2017 after 77 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 K953076 (1997). 15 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 34 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 4.
- K120340: Venus Facet Screw System, Apollo Spine, Inc. (2012) Summary page 4.
- K131417: Facet Fixx, Nexxt Spine, LLC (2013) Summary page 4.

## Most influential descendants
- 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
- K232468: SC Medica FFX (2024), 3 descendants of its own
- K240086: Ion 3D (2024), 3 descendants of its own
- K252153: FFX Facet Fixation System (2025), 2 descendants of its own

## Indications for use
The ALLY™ Facet Screws are 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; and 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 ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.

Source page: https://510kreport.com/device/K163374
Methodology: https://510kreport.com/methodology