Cleared Traditional

K162353 - MICATM Screw System

K162353 is an FDA 510(k) clearance for MICATM Screw System, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K162353 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
233d
Days
Class 2
Risk

K162353 is an FDA 510(k) clearance for the MICATM Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on April 13, 2017 after a review of 233 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K162353

510(k) Number K162353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2016
Decision Date April 13, 2017
Days to Decision 233 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
111d slower than avg
Panel avg: 122d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 939
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K162353.
CAPTIVATE™ Compression Screws
K162825 · Globus Medical, Inc. · May 2017
HV Screw System
K170889 · Wrightmedicaltechnologyinc · Apr 2017
Foot and Hand Motion
K170012 · Newclip Technics · Apr 2017
OsteoMed ExtremiFix Mid and Large Screw System
K163303 · Osteomed, LLC · Apr 2017
BePOD Cannulated Arthrodesis Screws
K170040 · Fournitures Hospitalieres Industrie · Apr 2017
OrthoSolutions 'System26' Bone Screws
K163489 · Ortho Solutions UK Limited · Mar 2017