# K093670: Modification to: Oasys System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Mar 18, 2010 after 111 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K853033 (1985). 19 ancestors in all.
41 later devices descend from it; 2 cite it directly.
1 of 61 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.

## Most influential descendants
- K111719: Oasys Spinal System (2012), 39 descendants of its own
- K142741: OASYS System (2015), 37 descendants of its own
- K150753: OASYS System (2015), 34 descendants of its own
- 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

## Recalls of this device
- May 30, 2013 · Class I · Z-1976-2013: Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.

## 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 System, SR90D System and Xia 4.5 Spinal System via the rod-to-rod connectors.

Source page: https://510kreport.com/device/K093670
Methodology: https://510kreport.com/methodology