# K970285: Aesuclap Socon Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jun 25, 1997 after 152 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Spine System® by Aesculap JBS: named in the summary without a submission number
- (no number) TSRH Spinal Screws & System by Sofamor Danek: named in the summary without a submission number
- (no number) Selby System by Advanced Spine Fixation System Inc.: named in the summary without a submission number
- (no number) VSP® Spinal Fixation System by AcroMed Corp.: named in the summary without a submission number
- (no number) SYNERGY™ Posterior Spinal System by Cross Medical Products Inc.: named in the summary without a submission number
- (no number) Varifix System by Advanced Spine Fixation System Inc.: named in the summary without a submission number

## Most influential descendants
- K993551: Socon Spinal System (2000), 0 descendants of its own

## Indications for use
The Aesculap SOCON® Spinal System presented in this submission is intended only for patients with severe spondylolisthesis grades 3 and 4, at the L5-S1 vertebral joint, utilizing autologous bone graft, who are having the device fixed or attached to the lumbar and sacral spine and who are having the implants removed after the development of a solid fusion mass. Levels of pedicle screw fixation for this indication are from L3 to S1.

Source page: https://510kreport.com/device/K970285
Methodology: https://510kreport.com/methodology