Cleared Special

K040212 - TRIGEN INTERTAN

K040212 is the FDA 510(k) clearance for TRIGEN INTERTAN by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code JDS) cleared through the Special 510(k) pathway after a 21-day FDA review.

K040212 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
21d
Days
Class 2
Risk

K040212 is an FDA 510(k) clearance for the TRIGEN INTERTAN. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K040212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2004
Decision Date February 20, 2004
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDS Nail, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDS Nail, Fixation, Bone

All 37
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K040212.
TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS
K051557 · Smith & Nephew, Inc. · Jun 2005
KNEE FUSION NAIL
K050938 · Smith & Nephew, Inc. · May 2005
SYNTHES (USA) TIBIAL NAIL SYSTEM EX
K040762 · Synthes (Usa) · Apr 2004
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
K033071 · Synthes (Usa) · Nov 2003
BNF
K021782 · Aap Implantate AG · Aug 2002
SYNTHES PROXIMAL HUMERAL NAIL
K002729 · Synthes (Usa) · Oct 2000