# K102995: Talon Spinal System

- Pathway: 510(k) (Special)
- Applicant: Spine360
- Decided: Feb 2, 2011 after 117 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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 K001044 (2000). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071824: Acme Talon Pedicle Screw, Acme Spine, LLC (2007) Summary page 1.
- K001044: Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw System, Acme Spine, LLC (2000)

## Most influential descendants
- K241494: Pantheon Pedicle Screw and Iliac Bolt Fixation System (2024), 1 descendant of its own
- K252219: Cervical Interbody and VBR Fusion System (2026), 0 descendants of its own
- K152920: Savannah-T® Pedicle Screw System (2016), 0 descendants of its own
- K153152: Syzygy Stabilization System (2016), 0 descendants of its own

## Indications for use
The Spine 360 Talon Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K102995
Methodology: https://510kreport.com/methodology