Cleared Special

K162189 - ANAX™ 5.5 Spinal System

K162189 is an FDA 510(k) clearance for ANAX 5.5 Spinal System, manufactured by U&I Corporation. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 26-day FDA review.

K162189 · U&I Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
26d
Days
Class 2
Risk

K162189 is an FDA 510(k) clearance for the ANAX™ 5.5 Spinal System. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by U&I Corporation (Uijeongbu-Si, KR). The FDA issued a Cleared decision on August 30, 2016 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K162189

510(k) Number K162189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2016
Decision Date August 30, 2016
Days to Decision 26 days
Submission Type Special
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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K162189.
CastleLoc Spinal Fixation System
K162801 · L & K Biomed Co., Ltd. · Nov 2016
FixxSure® X-Link
K162143 · Innovasis, Inc. · Sep 2016
Spinal fixation system
K161151 · Canwell Medical Co., Ltd. · Sep 2016
HC Spinal System
K151362 · Hung Chun Bio-S Co., Ltd. · May 2016
Zavation Spinal System
K153404 · Zavation, LLC · Apr 2016
Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
K160020 · Captiva Spine · Mar 2016
K162189 · ANAX™ 5.5 Spinal System
Download PDF FDA Summary U&I Corporation