Cleared Traditional

K162143 - FixxSure® X-Link

K162143 is an FDA 510(k) clearance for FixxSure X-Link, manufactured by Innovasis, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K162143 · Innovasis, Inc. · Orthopedic device
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Sep 2016
Decision
53d
Days
Class 2
Risk

K162143 is an FDA 510(k) clearance for the FixxSure® X-Link. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 23, 2016 after a review of 53 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. 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 Innovasis, Inc. devices

FDA 510(k) Submission Details - K162143

510(k) Number K162143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2016
Decision Date September 23, 2016
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
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 260
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K162143.
Reliance Spinal Screw System
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ANAX™ 5.5 Spinal System
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HC Spinal System
K151362 · Hung Chun Bio-S Co., Ltd. · May 2016
Zavation Spinal System
K153404 · Zavation, LLC · Apr 2016