Cleared Traditional

K944092 - ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM

K944092 is an FDA 510(k) clearance for ADDITIONAL ACCESSORIES FOR THE ORTHOFIX..., manufactured by Orthofix Srl. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K944092 · Orthofix Srl · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
225d
Days
Class 2
Risk

K944092 is an FDA 510(k) clearance for the ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Orthofix Srl (Rockville, US). The FDA issued a Cleared decision on April 4, 1995 after a review of 225 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Orthofix Srl devices

FDA 510(k) Submission Details - K944092

510(k) Number K944092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1994
Decision Date April 04, 1995
Days to Decision 225 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
103d slower than avg
Panel avg: 122d · This submission: 225d
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 55
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K944092.
MONOTUBE TUBE-TO-TUBE CLAMP
K954667 · Howmedica Corp. · Jan 1996
EXTERNAL FIXATOR
K952330 · Acu Med, Inc. · Oct 1995
HOFFMANN II EXTERNAL FIXATION SYSTEM
K952730 · Howmedica Corp. · Sep 1995
EXTERNAL FIXATOR
K943857 · Acu Med, Inc. · Jan 1995
ACE PELVIC STABILIZER
K933968 · Ace Medical Co. · Jun 1994
PELVIC C-CLAMP
K922796 · Synthes (Usa) · Mar 1994