# K100147: S4 Cervical Occipital Plate Spinal System

- Pathway: 510(k) (Special)
- Applicant: Aesculap Implant System, Inc.
- Decided: Jul 23, 2010 after 185 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: 1 generation back to K062012 (2007). 1 ancestor in all.
24 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062012: S4 Cervical Occipital Plate Spinal System, Aesculap, Inc. (2007) Summary page 1.

## Most influential descendants
- K121725: Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System (2012), 17 descendants of its own
- K171369: M.U.S.T. MINI Posterior Cervical Screws System (2017), 8 descendants of its own
- K200130: M.U.S.T. MINI Posterior Cervical Screws System (2020), 6 descendants of its own
- K112905: Compress (R) Segmental Humeral Replacement System (2012), 5 descendants of its own
- K200936: Invictus™ CT Spinal Fixation System (2020), 3 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and thoracic spine (C1 -T3) and occipito-cervico-thoracic junction (occiput-T3) and are intended for the following: * DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies * Spondylolisthesis * Spinal Stenosis * Fracture/dislocation * Failed previous fusion * Atlanto/axial fracture with instability * Occipitocervical dislocation * Revision of previous cervical spine surgery * Tumors The occipital bone screws are limited to occipital fixation only. 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 (C1 -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 place in the cervical spine.

Source page: https://510kreport.com/device/K100147
Methodology: https://510kreport.com/methodology