Cleared Traditional

K031657 - STRYKER SPINE OASYS BONE SCREW

K031657 · Howmedica Osteonics Corp. · Orthopedic device
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Aug 2003
Decision
86d
Days
-
Risk

K031657 is an FDA 510(k) clearance for the STRYKER SPINE OASYS BONE SCREW. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 22, 2003 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K031657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2003
Decision Date August 22, 2003
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 48
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K031657.
ZYFUSE FACET FIXATION SYSTEM
K090952 · Globus Medical, Inc. · Jul 2009
LIFE SPINE FACET SCREW SPINAL SYSTEM
K090865 · Life Spine · Jun 2009
CORRIDOR FIXATION SYSTEM
K083442 · Globus Medical, Inc. · Feb 2009
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
K021705 · Medtronic Sofamor Danek, Inc. · Jul 2002
NUVASIVE TRIAD FACET SCREW SYSTEM
K020411 · Nuvasive, Inc. · Mar 2002
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829 · Medtronic Sofamor Danek, Inc. · Dec 2001