Cleared Traditional

K032394 - STRYKER SPINE OASYS SYSTEM

K032394 is an FDA 510(k) clearance for STRYKER SPINE OASYS SYSTEM, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K032394 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
200d
Days
Class 2
Risk

K032394 is an FDA 510(k) clearance for the STRYKER SPINE OASYS SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 200 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K032394

510(k) Number K032394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2003
Decision Date February 20, 2004
Days to Decision 200 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
78d slower than avg
Panel avg: 122d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 246
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K032394.
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POSTERIOR CABLE SCREW
K022908 · Pioneer Surgical Technology · Jan 2004
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495 · Medtronic Sofamor Danek, Inc. · Dec 2003