# K071824: Acme Talon Pedicle Screw

- Pathway: 510(k) (Special)
- Applicant: Acme Spine, LLC
- Decided: Sep 4, 2007 after 63 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
No predicates in its family tree.
103 later devices descend from it; 6 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K001044: Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw System, Acme Spine, LLC (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K081331: Fixxsure Cross Link (2008), 91 descendants of its own
- K110692: Streamline TL Spinal System (2011), 89 descendants of its own
- K111502: Streamline TL Spinal System (2011), 88 descendants of its own
- K132049: Thunderbolt and Lancer  Pedicle Screw Systems (2014), 82 descendants of its own
- K160775: Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (2016), 73 descendants of its own

## Indications for use
The Acme 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 (pseudarthrosis).

Source page: https://510kreport.com/device/K071824
Methodology: https://510kreport.com/methodology