Cleared Special

K073325 - LEGION POROUS PRIMARY

K073325 is an FDA 510(k) clearance for LEGION POROUS PRIMARY, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code MBH cleared through the Special 510(k) pathway after a 23-day FDA review.

K073325 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
23d
Days
Class 2
Risk

K073325 is an FDA 510(k) clearance for the LEGION POROUS PRIMARY. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on December 20, 2007 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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

FDA 510(k) Submission Details - K073325

510(k) Number K073325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2007
Decision Date December 20, 2007
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

MBH Device Classification - Class 2, Special Controls

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 142
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K073325.
APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]
K080842 · Omni Life Science, Inc. · May 2008
REGENEREX TIBIAL COMPONENTS
K080361 · Biomet, Inc. · Apr 2008
TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE
K072575 · Stryker Orthopaedics · Jan 2008
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS
K072619 · Zimmer, Inc. · Nov 2007
NEXGEN TRABECULAR METAL TIBIAL TRAY
K072160 · Zimmer, Inc. · Sep 2007
GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM
K071790 · Smith & Nephew, Inc. · Aug 2007