# K062327: Modification to S4 Spinal System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Mar 14, 2007 after 216 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 10 generations back to K853033 (1985). 21 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 36 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.
- K060152: Modification to S4 Spinal System, Aesculap, Inc. (2006) Summary page 1.

## Most influential descendants
- K130887: S4C Navigation Instruments (2013), 13 descendants of its own
- K181890: Brainlab Compatible K2M Navigation Instruments (2018), 11 descendants of its own
- K192911: Brainlab Compatible K2M Navigation Instruments (2019), 9 descendants of its own
- K203205: Navigated Spine Instruments (2021), 8 descendants of its own
- K240662: Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece (2024), 7 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 (CI - 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/K062327
Methodology: https://510kreport.com/methodology