# K052317: Modification to:  Stryker Spine Oasys System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Sep 21, 2005 after 27 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: 1 generation back to K032394 (2004). 1 ancestor in all.
61 later devices descend from it; 7 cite it directly.
1 of 63 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032394: Stryker Spine Oasys System, Howmedica Osteonics Corp. (2004) Summary page 1.

## Most influential descendants
- K062853: Modification to Stryker Spine Oasys System (2006), 53 descendants of its own
- K072568: Modification to Oasys System (2007), 44 descendants of its own
- K080143: Modification to Stryker Spine Oasys System (2008), 43 descendants of its own
- K093670: Modification to: Oasys System (2010), 41 descendants of its own
- K111719: Oasys Spinal System (2012), 39 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 OASYSTM 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 be linked to the Xia Spinal System and SR90D System via the rod-to-rod connectors.

Source page: https://510kreport.com/device/K052317
Methodology: https://510kreport.com/methodology