Cleared Traditional

K010903 - TRI-FIX SPINAL FIXATION SYSTEM

K010903 is an FDA 510(k) clearance for TRI-FIX SPINAL FIXATION SYSTEM, manufactured by Endius, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K010903 · Endius, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
72d
Days
Class 2
Risk

K010903 is an FDA 510(k) clearance for the TRI-FIX SPINAL FIXATION SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Endius, Inc. (Plainville, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 72 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 Endius, Inc. devices

FDA 510(k) Submission Details - K010903

510(k) Number K010903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2001
Decision Date June 06, 2001
Days to Decision 72 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 184
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K010903.
PASS SPINAL SYSTEM
K013191 · Encore Orthopedics, Inc. · Oct 2001
PASS SPINAL SYSTEM
K012175 · Encore Orthopedics, Inc. · Jul 2001
ISOLA BAND CLAMP
K010972 · Depuyacromed · Jun 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010922 · Endius, Inc. · Jun 2001
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
K011437 · Interpore Cross Intl. · Jun 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011029 · Medtronic Sofamor Danek, Inc. · Jun 2001