# K060152: Modification to S4 Spinal System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Feb 3, 2006 after 14 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: 9 generations back to K853033 (1985). 20 ancestors in all.
32 later devices descend from it; 5 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050979: S4 Spinal System, Aesculap, Inc. (2005) Summary page 1.

## Most influential descendants
- K103414: Venus Cervical Spinal Fixation System (2011), 16 descendants of its own
- K120879: Lexus Cervical Fixation System (2012), 15 descendants of its own
- K062327: Modification to S4 Spinal System (2007), 14 descendants of its own
- K143278: LnK Posterior Cervical Fixation System (2015), 13 descendants of its own
- K130887: S4C Navigation Instruments (2013), 13 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and the thoracic spine (C1 - 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/K060152
Methodology: https://510kreport.com/methodology