# K031657: Stryker Spine Oasys Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 22, 2003 after 86 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K092568: Spartan S3 Facet System (2009), 29 descendants of its own
- K120340: Venus Facet Screw System (2012), 26 descendants of its own
- K163374: ALLY™ Facet Screws (2017), 18 descendants of its own
- K211855: Ion Facet Screw System (2022), 10 descendants of its own
- K230840: PMT Facet Fixation System, Lumbar (PMT FFS-LX) (2023), 9 descendants of its own

## Indications for use
The Stryker Spine Oasys Bone Screw is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The Stryker Spine Oasys Bone Screw is indicated for bilateral fixation, with or without bone graft, at single or multiple levels, from C2 to T3. The Stryker Spine Oasys Bone Screw is indicated for treating any or all of the following: Trauma, including fractures and/or dislocations Spondylolisthesis Spondylolysis Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity Degenerative disc disease (DDD) as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies Degenerative disease of the facets with instability

Source page: https://510kreport.com/device/K031657
Methodology: https://510kreport.com/methodology