Cleared Special

K061019 - TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS

K061019 is an FDA 510(k) clearance for TRIGEN META-NAIL RETROGRADE FEMORAL AND..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code JDS cleared through the Special 510(k) pathway after a 54-day FDA review.

K061019 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
54d
Days
Class 2
Risk

K061019 is an FDA 510(k) clearance for the TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS. 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 June 6, 2006 after a review of 54 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.

FDA 510(k) Submission Details - K061019

510(k) Number K061019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2006
Decision Date June 06, 2006
Days to Decision 54 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
68d faster than avg
Panel avg: 122d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

JDS Device Classification - Class 2, Special Controls

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 52
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K061019.
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
K072095 · Synthes (Usa) · Sep 2007
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM
K062872 · Synthes (Usa) · Mar 2007
KNEE FUSION NAIL
K061783 · Smith & Nephew, Inc. · Aug 2006
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
K061019 · TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS
Download PDF FDA Summary Smith & Nephew, Inc.