Cleared Traditional

K974186 - ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING

K974186 is an FDA 510(k) clearance for ORTHOFIX EXTERNAL FIXATION SCREW (PIN) ..., manufactured by Orthofix Srl. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K974186 · Orthofix Srl · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
131d
Days
Class 2
Risk

K974186 is an FDA 510(k) clearance for the ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Orthofix Srl (Rockville, US). The FDA issued a Cleared decision on March 18, 1998 after a review of 131 days - within the typical 510(k) review window.

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 - K974186

510(k) Number K974186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1997
Decision Date March 18, 1998
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 84
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K974186.
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
K982068 · Howmedica Corp. · Aug 1998
EXTERNAL FIXATION
K981716 · Avanta Orthopaedics, Inc. · Jul 1998
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
K980788 · Alphatec Mfg., Inc. · May 1998
EXTERNAL FIXATOR
K974911 · Avanta Orthopaedics, Inc. · Mar 1998
HEIDELBERG EXTERNAL FIXATOR
K970751 · Smith & Nephew, Inc., Orthopaedic Div. · Apr 1997
COMPASS UNIVERSAL HINGE
K970713 · Smith & Nephew, Inc., Orthopaedic Div. · Apr 1997