Cleared Traditional

K060412 - ACTIVE UNICOMPARTMENTAL KNEE SYSTEM

K060412 is an FDA 510(k) clearance for ACTIVE UNICOMPARTMENTAL KNEE SYSTEM, manufactured by Australian Surgical Design & Manufacture. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K060412 · Australian Surgical Design & Manufacture · Orthopedic device
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May 2006
Decision
90d
Days
Class 2
Risk

K060412 is an FDA 510(k) clearance for the ACTIVE UNICOMPARTMENTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Australian Surgical Design & Manufacture (Annapolis, US). The FDA issued a Cleared decision on May 17, 2006 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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 Australian Surgical Design & Manufacture devices

FDA 510(k) Submission Details - K060412

510(k) Number K060412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2006
Decision Date May 17, 2006
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRY Device Classification - Class 2, Special Controls

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 80
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K060412.
DEPUY GCK TIBIAL COMPONENTS
K070267 · DePuy Orthopaedics, Inc. · Aug 2007
TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
K063515 · Biomet Manufacturing, Inc. · Feb 2007
REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
K061681 · Biomet Manufacturing Corp · Oct 2006
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
K053299 · Biomet Manufacturing, Inc. · Jan 2006
UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
K050764 · Corin USA · Aug 2005
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
K042093 · Biomet, Inc. · Nov 2004