Cleared Special

TRIFIX SPINAL FIXATION SYSTEM (K001627) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K001627 · Endius, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
8d
Days
Class 2
Risk

K001627 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 June 3, 2000 after a review of 8 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

Submission Details

510(k) Number K001627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2000
Decision Date June 03, 2000
Days to Decision 8 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 122d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 35
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K001627.
MODIFICATION TO OSTEONICS SPINAL SYSTEM
K010845 · Howmedica Osteonics Corp. · Apr 2001
SOCON SPINAL SYSTEM
K003463 · Aesculap, Inc. · Apr 2001
OPUS ROD FIXATION SYSTEM
K003490 · Howmedica Osteonics Corp. · Dec 2000
XIA SPINE SYSTEM HOOKS
K001319 · Howmedica Osteonics Corp. · May 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K000094 · Medtronic Sofamor Danek USA, Inc. · Feb 2000
SOCON SPINAL SYSTEM
K993551 · Aesculap, Inc. · Jan 2000