Cleared Traditional

K010369 - CLARIS PLATE SYSTEM

K010369 is an FDA 510(k) clearance for CLARIS PLATE SYSTEM, manufactured by Ortho Tec, LLC. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K010369 · Ortho Tec, LLC · Orthopedic device
Download Printable Device Report (PDF)
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May 2001
Decision
90d
Days
Class 2
Risk

K010369 is an FDA 510(k) clearance for the CLARIS PLATE SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Ortho Tec, LLC (Beverly Hills, US). The FDA issued a Cleared decision on May 8, 2001 after a review of 90 days - within the typical 510(k) review window.

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 Ortho Tec, LLC devices

FDA 510(k) Submission Details - K010369

510(k) Number K010369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2001
Decision Date May 08, 2001
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 180
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K010369.
SPIRAL RADIUS 90-D SST SYSTEM
K012273 · United States Surgical, A Division of Tyco Healthc · Aug 2001
SCS CLOSED SCREW
K003733 · Ortho Tec, LLC · May 2001
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
K011182 · Depuyacromed · May 2001
MODIFICATION TO OSTEONICS SPINAL SYSTEM
K010845 · Howmedica Osteonics Corp. · Apr 2001
MOSS MIAMI 5.5MM TITANIUM PIN NUT
K010742 · Depuyacromed · Apr 2001
SOCON SPINAL SYSTEM
K003463 · Aesculap, Inc. · Apr 2001