Cleared Traditional

K000766 - TRI-FIX SPINAL FIXATION SYSTEM

K000766 is the FDA 510(k) clearance for TRI-FIX SPINAL FIXATION SYSTEM by Endius, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K000766 · Endius, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2000
Decision
84d
Days
Class 2
Risk

K000766 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 1, 2000 after a review of 84 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

Submission Details

510(k) Number K000766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2000
Decision Date June 01, 2000
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K000766.
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735 · Blackstone Medical, Inc. · May 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011067 · Medtronic Sofamor Danek, Inc. · May 2001
SMALL STATURE USS
K994121 · Synthes (Usa) · Oct 2000
MULTI-AXIAL CROSS (MAC) CONNECTOR
K000965 · Howmedica Osteonics Corp. · May 2000
SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP
K000876 · Interpore Cross Intl. · Apr 2000
MODIFICATION TO TSRH SPINAL SYSTEM
K000991 · Medtronic Sofamor Danek, Inc. · Apr 2000