# K022768: Amt Polyaxial Pedicle Screw

- Pathway: 510(k) (Traditional)
- Applicant: Micron Precision Engineering, Inc.
- Decided: Nov 13, 2002 after 84 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 K002059 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002059: Amt Spinal System, Micron Precision Engineering, Inc. (2000) Summary page 2.
- (no number) Spine System Evolution - Aesculap: named in the summary without a submission number
- (no number) Global Spinal Fixation System - Forex: named in the summary without a submission number
- (no number) Global Spinal Fixation System - U & I Corporation: named in the summary without a submission number
- (no number) Spiral Radius 90D - Surgical Dynamics: named in the summary without a submission number
- (no number) Trinity Polyaxial Screw - Corin Spinal Systems: named in the summary without a submission number

## Indications for use
When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients (MNI), The AMT SpinalTMSystem is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (1) severe degenerative spondylolithesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudoarthrosis). The AMT SpinalTMSystem is intended for skeletally mature patients (MNH): (1) having severe spondylolithesis (Grades 3 and 4) at the L5S1 vertebral joint; (2) who are receiving fusion by autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K022768
Methodology: https://510kreport.com/methodology