Cleared Traditional

K091309 - REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX

K091309 is an FDA 510(k) clearance for REVOLUTION FEMORAL INTRAMEDULLARY NAIL ..., manufactured by Dgimed Ortho, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K091309 · Dgimed Ortho, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
185d
Days
Class 2
Risk

K091309 is an FDA 510(k) clearance for the REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Dgimed Ortho, Inc. (Minnetonka, US). The FDA issued a Cleared decision on November 5, 2009 after a review of 185 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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.

FDA 510(k) Submission Details - K091309

510(k) Number K091309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2009
Decision Date November 05, 2009
Days to Decision 185 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
63d slower than avg
Panel avg: 122d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 515
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K091309.
WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)
K092110 · Sonoma Orthopedic Products, Inc. · Jan 2010
DYNA LOCKING IM NAIL
K092771 · U&I Corp. · Dec 2009
MAGNUM NAIL
K093089 · Robert Reid, Inc. · Nov 2009
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
K091566 · Zimmer GmbH · Oct 2009
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW
K092646 · Synthes (Usa) · Sep 2009
BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
K091976 · Biomet Trauma · Aug 2009
K091309 · REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX
Download PDF FDA Summary Dgimed Ortho, Inc.