# K001044: Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Acme Spine, LLC
- Decided: Nov 3, 2000 after 217 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K102995: Talon Spinal System (2011), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K001044
Methodology: https://510kreport.com/methodology