Cleared Special

K031941 - HOFFMANN II COMPACT BALTIMORE COUPLING

K031941 is an FDA 510(k) clearance for HOFFMANN II COMPACT BALTIMORE COUPLING, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Special 510(k) pathway after a 30-day FDA review.

K031941 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
30d
Days
Class 2
Risk

K031941 is an FDA 510(k) clearance for the HOFFMANN II COMPACT BALTIMORE COUPLING. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on July 24, 2003 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031941

510(k) Number K031941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2003
Decision Date July 24, 2003
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 84
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K031941.
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WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
K030519 · Hand Biomechanics Lab, Inc. · Jun 2003
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676 · Smith & Nephew, Inc. · Sep 2002
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
K022065 · Sintea Biotech, Inc. · Aug 2002
K031941 · HOFFMANN II COMPACT BALTIMORE COUPLING
Download PDF FDA Summary Howmedica Osteonics C…