# K150539: OASYS System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: May 12, 2015 after 70 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953076 (1997). 5 ancestors in all.
34 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.
- K143471: VERTEX Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.

## Most influential descendants
- K151755: OASYS (r) System (2015), 33 descendants of its own
- K153370: Caspian OCT/MESA Mini/DENALI Mini Spinal System (2016), 17 descendants of its own
- K171444: YUKON OCT Spinal System (2017), 13 descendants of its own
- K162136: CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System (2016), 12 descendants of its own
- K200793: LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System (2020), 11 descendants of its own

## Indications for use
The Stryker Spine OASYS® System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Stryker Spine OASYS® System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Stryker Spine OASYS® System can be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods. The Stryker Spine OASYS® System can also be linked to the polyaxial screws of the Xia® II and Xia® 3 Systems via the saddle connector.

Source page: https://510kreport.com/device/K150539
Methodology: https://510kreport.com/methodology