510(k) · Cleared
ClearedStryker Spine Oasys Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · MRW System, Facet Screw Spinal Device
Cleared on Aug 22, 2003 after an 86-day review. The FDA summary names no predicate by number. 33 later devices descend from it.
- Decided
- Aug 22, 2003
- Review
- 86 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 3 citing it directly.
- This deviceK031657 Stryker Spine Oasys Bone ScrewHowmedica Osteonics Corp. · 2003
- Descendant · cites it directly · 29 of its ownK092568 Spartan S3 Facet SystemAmendia, Inc. · 2009
- Descendant · 2 generations on · 26 of its ownK120340 Venus Facet Screw SystemApollo Spine, Inc. · 2012
- Descendant · 2 generations on · 18 of its ownK163374 ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017
- Descendant · 3 generations on · 10 of its ownK211855 Ion Facet Screw SystemSurGenTec, LLC · 2022
- Descendant · 3 generations on · 9 of its ownK230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc. · 2023
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K092568Spartan S3 Facet SystemAmendia, Inc. · 2009 · cites it directly29descendants
- K120340Venus Facet Screw SystemApollo Spine, Inc. · 2012 · 2 generations on26descendants
- K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017 · 2 generations on18descendants
- K211855Ion Facet Screw SystemSurGenTec, LLC · 2022 · 3 generations on10descendants
- K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc. · 2023 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031657 | Stryker Spine Oasys Bone Screw | Howmedica Osteonics Corp. | 2003 | — |
| +1 | K092568 | Spartan S3 Facet System | Amendia, Inc. | 2009 | — |
| +2 | K120340 | Venus Facet Screw System | Apollo Spine, Inc. | 2012 | — |
| +2 | K163374 | ALLY™ Facet Screws | Providence Medical Technology, Inc. | 2017 | — |
| +3 | K211855 | Ion Facet Screw System | SurGenTec, LLC | 2022 | — |
| +3 | K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Providence Medical Technology, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRW device
- #1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (33)
See all 333 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092568 (Amendia, Inc., 2009) has gone furthest, with 29 descendants of its own.
How does its category compare?
All MRW devicesMRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRW
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRW
3in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRW
3in 2025
MAUDE reports naming product code MRW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 3 | 88 | 0 | 0 |
| 2009 | 6 | 89 | 0 | 2 |
| 2010 | 6 | 108 | 0 | 7 |
| 2011 | 3 | 122 | 3 | 62 |
| 2012 | 4 | 119 | 0 | 6 |
| 2013 | 7 | 110 | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 90 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 3 | 252 | 0 | 0 |
| 2023 | 3 | 190 | 0 | 1 |
| 2024 | 7 | 50 | 0 | 2 |
| 2025 | 7 | 97 | 0 | 3 |
| 2026 | 5 | 169 | 0 | — |
What is it indicated for?
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…
Read the full statement (140 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031657: Stryker Spine Oasys Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031657
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026