Cleared Special

K010535 - TRIFIX SPINAL FIXATION SYSTEM

K010535 is an FDA 510(k) clearance for TRIFIX SPINAL FIXATION SYSTEM, manufactured by Endius, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 24-day FDA review.

K010535 · Endius, Inc. · Orthopedic device
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Mar 2001
Decision
24d
Days
Class 2
Risk

K010535 is an FDA 510(k) clearance for the TRIFIX SPINAL FIXATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Endius, Inc. (Plainville, US). The FDA issued a Cleared decision on March 19, 2001 after a review of 24 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.

View all Endius, Inc. devices

FDA 510(k) Submission Details - K010535

510(k) Number K010535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2001
Decision Date March 19, 2001
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 170
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K010535.
SOCON SPINAL SYSTEM
K003463 · Aesculap, Inc. · Apr 2001
TSRH SPINAL SYSTEM
K010720 · Medtronic Sofamor Danek, Inc. · Apr 2001
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS
K010776 · Corin USA · Apr 2001
CD HORIZON SPINAL SYSTEM
K010249 · Medtronic Sofamor Danek, Inc. · Feb 2001
MODIFICATION TO EBI SPINELINK SYSTEM
K003764 · Ebi, L.P. · Jan 2001
CD HORIZON SPINAL SYSTEM
K000641 · Medtronic Sofamor Danek, Inc. · Dec 2000