# K960107: DDS Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: May 3, 1996 after 113 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
Longest line of descent: 1 generation back to K894184 (1990). 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)
- K894184: Biedermann Motech Universal Spinal System, Biedermann Motech GmbH (1990) Summary page 1.

## Indications for use
It is intended for patients with severe spondylolisthesis (Grades 3 and 4) having fusions at the L5-S1 joint using autogenous bone graft, to be fixed/attached to the lumbar and sacral spine. The components are intended to be removed after development of a solid fusion mass. The screws are limited to L3-S1 or iliac screw fixation.

Source page: https://510kreport.com/device/K960107
Methodology: https://510kreport.com/methodology