Cleared Traditional

OASYS System (K150753) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150753 · Stryker Corporation · Orthopedic device
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Jun 2015
Decision
78d
Days
Class 2
Risk

K150753 is an FDA 510(k) clearance for the OASYS System. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on June 9, 2015 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. 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 Stryker Corporation devices

Submission Details

510(k) Number K150753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2015
Decision Date June 09, 2015
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 63
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K150753.
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ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
K110963 · Globus Medical, Inc. · May 2011
SP-FIX SPINOUS PROCESS FIXATION PLATE
K102195 · Globus Medical, Inc. · Jan 2011
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
K091689 · Synthes (Usa) · Jul 2009
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
K090565 · Globus Medical, Inc. · Jun 2009