Cleared Traditional

K053094 - ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K053094 · Advanced Bio-Surfaces, Inc. · Orthopedic device
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Feb 2006
Decision
95d
Days
Class 2
Risk

K053094 is an FDA 510(k) clearance for the ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 906.... Classified as Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented) (product code HSH), Class II - Special Controls.

Submitted by Advanced Bio-Surfaces, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 6, 2006 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3590 - 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 Advanced Bio-Surfaces, Inc. devices

Submission Details

510(k) Number K053094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2005
Decision Date February 06, 2006
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3590
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.