# K062012: S4 Cervical Occipital Plate Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Feb 9, 2007 after 207 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 2 cite it directly.
0 of 28 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) Summit Occipito-Cervico-Thoracic (OCT) Spinal Systems: named in the summary without a submission number
- (no number) S4 Cervical Spinal System: named in the summary without a submission number

## Most influential descendants
- K100147: S4 Cervical Occipital Plate Spinal System (2010), 24 descendants of its own
- 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

## Recalls of this device
- Sep 8, 2020 · Class II · Z-1445-2022: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
- Sep 8, 2020 · Class II · Z-1446-2022: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
- Sep 8, 2020 · Class II · Z-1443-2022: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
- Sep 8, 2020 · Class II · Z-1444-2022: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
- Sep 8, 2020 · Class II · Z-1448-2022: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
- Sep 8, 2020 · Class II · Z-1447-2022: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.

## Indications for use
When intended to promote fusion of the cervical spine and thoracic spine (Cl-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 (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 place in the cervical spine.

Source page: https://510kreport.com/device/K062012
Methodology: https://510kreport.com/methodology