Cleared Traditional

K083779 - MAK OSS KNEE FEMORAL COMPONENTS

K083779 is an FDA 510(k) clearance for MAK OSS KNEE FEMORAL COMPONENTS, manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K083779 · Biomet Manufacturing Corp · Orthopedic device
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Apr 2009
Decision
105d
Days
Class 2
Risk

K083779 is an FDA 510(k) clearance for the MAK OSS KNEE FEMORAL COMPONENTS. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on April 3, 2009 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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.

View all Biomet Manufacturing Corp devices

FDA 510(k) Submission Details - K083779

510(k) Number K083779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2008
Decision Date April 03, 2009
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRO Device Classification - Class 2, Special Controls

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 81
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K083779.
METS SMILES TOTAL KNEE REPLACEMENT
K120992 · Stanmore Implants Worldwide , Ltd. · Sep 2012
ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
K110940 · Zimmer, Inc. · Jul 2011
LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
K091453 · DePuy Orthopaedics, Inc. · Aug 2009
ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
K083827 · Biomet Manufacturing Corp · Feb 2009
LEGION HINGE KNEE SYSTEM
K081111 · Smith & Nephew, Inc. · Jul 2008
SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
K080330 · Biomet, Inc. · Jun 2008