Cleared Traditional

K022065 - SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X

K022065 is an FDA 510(k) clearance for SINTEA BIOTECH TRAUMAFIX SYSTEM, manufactured by Sintea Biotech, Inc.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K022065 · Sintea Biotech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
42d
Days
Class 2
Risk

K022065 is an FDA 510(k) clearance for the SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Sintea Biotech, Inc. (Miami Beach, US). The FDA issued a Cleared decision on August 6, 2002 after a review of 42 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 Sintea Biotech, Inc. devices

FDA 510(k) Submission Details - K022065

510(k) Number K022065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2002
Decision Date August 06, 2002
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEC Device Classification - Class 2, Special Controls

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 52
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K022065.
KLSA MARTIN HAND DISTRACTOR
K042066 · KLS-Martin L.P. · Aug 2004
HOFFMANN II COMPACT BALTIMORE COUPLING
K031941 · Howmedica Osteonics Corp. · Jul 2003
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676 · Smith & Nephew, Inc. · Sep 2002
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K012193 · Smith & Nephew, Inc. · Jul 2002
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
K003848 · Howmedica Osteonics Corp. · Jan 2001
BREMER HALO SYSTEM TITANIUM SKULL PIN
K993099 · Depuyacromed · Dec 1999