Cleared Traditional

ORTHOFIX AXIALEXTERNAL FIXATION SYS. (K802814) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K802814 · Cintor Orthopaedic Div. · Orthopedic device
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Dec 1980
Decision
33d
Days
Class 2
Risk

K802814 is an FDA 510(k) clearance for the ORTHOFIX AXIALEXTERNAL FIXATION SYS.. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Cintor Orthopaedic Div. (Mchenry, US). The FDA issued a Cleared decision on December 10, 1980 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Cintor Orthopaedic Div. devices

Submission Details

510(k) Number K802814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1980
Decision Date December 10, 1980
Days to Decision 33 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 122d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEC Component, Traction, Invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JEC Component, Traction, Invasive

All 29
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K802814.
SABA-COOMBS MINI EXTERNAL FIXATOR
K842343 · Zimmer, Inc. · Sep 1984
OXFORD MARK 2 EXTERNAL FIXATOR
K833114 · Johnson & Johnson Professionals, Inc. · Oct 1983
DOUBLE BALL JOINT
K803166 · Howmedica Corp. · Jan 1981
EXTERNAL FIXATION SYSTEM
K802722 · Howmedica Corp. · Nov 1980
EXTENDED BALLJOINT GRIP
K802723 · Howmedica Corp. · Nov 1980
HOFFMAN LEG LENGTHENING DEVICE
K802776 · Howmedica Corp. · Nov 1980