Cleared Traditional

K131512 - KATIA SYSTEM

K131512 is an FDA 510(k) clearance for KATIA SYSTEM, manufactured by Shanghai Sanyou Medical Co, Ltd.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K131512 · Shanghai Sanyou Medical Co, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
71d
Days
Class 2
Risk

K131512 is an FDA 510(k) clearance for the KATIA SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Shanghai Sanyou Medical Co, Ltd. (Bartlett, US). The FDA issued a Cleared decision on August 7, 2013 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Shanghai Sanyou Medical Co, Ltd. devices

FDA 510(k) Submission Details - K131512

510(k) Number K131512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2013
Decision Date August 07, 2013
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 471
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K131512.
NUVASIVE DECADE LATERAL PLATE SYSTEM
K130868 · Nuvasive, Inc. · Aug 2013
ASPIRON ACP SYSTEM
K131200 · U&I Corporation · Aug 2013
TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM
K132012 · Zimmer Spine, Inc. · Aug 2013
PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM
K130427 · Pioneer Surgical Technology, Inc. · Jun 2013
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K130640 · Medtronic Sofamor Danek USA, Inc. · Jun 2013
AZURE ANTERIOR CERVICAL PLATE SYSTEM
K130825 · Orthofix, Inc. · May 2013