Cleared Traditional

ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM (K944092) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

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 28
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K944092.
TITANIUM TUBE TO TUBE CLAMP
K960782 · Synthes (Usa) · May 1996
MONOTUBE TUBE-TO-TUBE CLAMP
K954667 · Howmedica Corp. · Jan 1996
HOFFMANN II EXTERNAL FIXATION SYSTEM
K952730 · Howmedica Corp. · Sep 1995
PELVIC C-CLAMP
K922796 · Synthes (Usa) · Mar 1994
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
K934698 · Howmedica Corp. · Feb 1994
SYNTHES EXTERNAL FIXATION BONE CLIP
K894098 · Synthes (Usa) · Apr 1990