# K111719: Oasys Spinal System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Jan 19, 2012 after 213 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.
39 later devices descend from it; 2 cite it directly.
1 of 60 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). Our reading of the summary gave K032194, FDA’s number for Tigris DTS Automated Analyzer for Automating Amplified… (Gen-Probe, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Stryker Spine OASYS System”.
- 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.

## Cited in the summary but kept off the family tree
- K111183: Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods), Orthofix, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K171444: YUKON OCT Spinal System (2017), 13 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 Gasys 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 * Atlanta/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 (TI -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 (C I-T3) spine. The Stryker Spine OASYS® System can be linked to the Xiag 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 Xia® 11 and Xia®V 3 System via the saddle connector.

Source page: https://510kreport.com/device/K111719
Methodology: https://510kreport.com/methodology