# K050979: S4 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jul 27, 2005 after 99 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: 8 generations back to K853033 (1985). 19 ancestors in all.
67 later devices descend from it; 12 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031985: Spinal Concepts Inc. Nex-Link Spinal Fixation System, Spinal Concepts, Inc. (2003) Summary page 2.
- K042789: Vertex Reconstruction System, Medtronic Sofamor Danek (2004) Summary page 2.
- K042524: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2004) Summary page 2.
- K013222: Summit Occipito-Cervico- Thoracic (Oct) Spinal System, Depuyacromed (2001) Summary page 2.
- K030103: Summit Oct Spinal System Minipolyaxial Screws, Depuyacromed (2003) Summary page 2.
- K041203: Summit Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 2.

## Most influential descendants
- K060152: Modification to S4 Spinal System (2006), 32 descendants of its own
- K103414: Venus Cervical Spinal Fixation System (2011), 16 descendants of its own
- K120879: Lexus Cervical Fixation System (2012), 15 descendants of its own
- K110197: Exactech Gibralt Spinal System (2011), 15 descendants of its own
- K062327: Modification to S4 Spinal System (2007), 14 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and the thoracic spine (Cl - T3), the S4 Spinal System is intended for the following; * DDD (Neck pain pf discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) * Spondylolisthesis * Spinal stenosis * Fracture/dislocation * Failed previous fusion * Tumors The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (Cl - T3) spine. The use of the polyaxial screws is limited to placement in T1 - T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K050979
Methodology: https://510kreport.com/methodology