# K964275: Alpha Posterior Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Jan 14, 1997 after 81 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The ALPHA™ Posterior Spinal System is limited to non-cervical use. All implant components of the ALPHA™ Posterior Spinal System are intended for posterior spinal fixation. The ALPHA™ Posterior Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The ALPHA™ screws are indicated only for insertion no higher than L3 and not lower than the sacrum. CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates, ALPHA™ Low Profile MULTI-SPAN™ CROSSLINK® plates, TSRH® Low Profile CROSSLINK® plates, and TSRH® Low Profile CROSSLINK® Offset plates are intended for posterior thoracic, lumbar, and/or sacral use only.

Source page: https://510kreport.com/device/K964275
Methodology: https://510kreport.com/methodology