Cleared Traditional

K053094 - ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056

K053094 is an FDA 510(k) clearance for ORTHOGLIDE MEDICAL KNEE IMPLANT AND INS..., manufactured by Advanced Bio-Surfaces, Inc.. The device is a Class 2 Orthopedic device with product code HSH cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K053094 · Advanced Bio-Surfaces, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K053094

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.

HSH Device Classification - Class 2, Special Controls

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.