FDA 510(k)

GENESIS II TOTAL KNEE SYSTEM

K-Number: K030612 · 2003-05-27

Decision Date2003-05-27

Product CodeMBH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

GENESIS II TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2003-05-27 under 510(k) number K030612. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS II TOTAL KNEE SYSTEM?

GENESIS II TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2003-05-27. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K030612.

When did GENESIS II TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

GENESIS II TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2003-05-27, under 510(k) number K030612.

Who is the listed applicant for GENESIS II TOTAL KNEE SYSTEM?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENESIS II TOTAL KNEE SYSTEM?

The FDA product code for GENESIS II TOTAL KNEE SYSTEM is MBH.

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Other records listing Smith & Nephew, Inc. as applicant

K261462LANDMARK Total Knee System K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Related Devices (Code: MBH)

K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.