FDA 510(k)

SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION

K-Number: K121393 · 2012-08-07

Decision Date2012-08-07

Product CodeMBH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION 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 2012-08-07 under 510(k) number K121393. 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 SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION?

SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION is a medical device that received FDA 510(k) clearance on 2012-08-07. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K121393.

When did SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION receive FDA 510(k) clearance?

SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION received FDA 510(k) clearance on 2012-08-07, under 510(k) number K121393.

Who is the listed applicant for SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION?

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 SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION?

The FDA product code for SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION 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

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