# K032394: Stryker Spine Oasys System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 20, 2004 after 200 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
No predicates in its family tree.
230 later devices descend from it; 14 cite it directly.
2 of 231 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 no predicate by number.

## Most influential descendants
- K050391: Protex CT Cervicothoracic Spinal System (2005), 148 descendants of its own
- K081906: Protex CT Cervicothoracic Spinal System (2008), 104 descendants of its own
- K090565: Ellipse Occipito-Cerico-Thoracic Spinal System (2009), 101 descendants of its own
- K110963: Ellipse Occipito-Cervico-Thoracic Spinal System (2011), 98 descendants of its own
- K123783: Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants (2013), 97 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Stryker Spine Oasys System is intended for: * Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * Spondylolisthesis * Spinal Stenosis * Fracture/Dislocation * Atlanto/axial fracture with instability * Occipitocervical dislocation * Revision of previous cervical spine surgery * Tumors When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine. The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. 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 Stryker Spine Oasys System can also be linked to the Xia Spinal System via the rod to rod connector

Source page: https://510kreport.com/device/K032394
Methodology: https://510kreport.com/methodology