# K101183: Modification to: Oasys System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Nov 9, 2010 after 195 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K853033 (1985). 20 ancestors in all.
No later device cites it as a predicate yet.
1 of 21 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.
- K052317: Modification to:  Stryker Spine Oasys System, Stryker Spine (2005) Summary page 1.
- K062853: Modification to Stryker Spine Oasys System, Stryker Spine (2006) Summary page 1.
- K072568: Modification to Oasys System, Stryker Spine (2007) Summary page 1.
- K080143: Modification to Stryker Spine Oasys System, Stryker Spine (2008) Summary page 1.
- K093670: Modification to: Oasys System, Stryker Spine (2010) Summary page 1.

## 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). 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® System, SR90D System and Xia® 4.5 Spinal System. The Stryker Spine OASYS® System can also be linked to the Xia® System, SR90D System and Xia® 4.5 System via the rod-to-rod connectors and polyaxial screws of Xia® 1 and Xia® 3 Systems via the saddle connector.

Source page: https://510kreport.com/device/K101183
Methodology: https://510kreport.com/methodology