Cleared Traditional

K073233 - ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS (FDA 510(k) Clearance)

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

K073233 · Advanced Bio-Surfaces, Inc. · Orthopedic device
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Jan 2008
Decision
74d
Days
Class 2
Risk

K073233 is an FDA 510(k) clearance for the ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS. Classified as Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented) (product code HSH), Class II - Special Controls.

Submitted by Advanced Bio-Surfaces, Inc. (Andover, US). The FDA issued a Cleared decision on January 28, 2008 after a review of 74 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Bio-Surfaces, Inc. devices

Submission Details

510(k) Number K073233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2007
Decision Date January 28, 2008
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
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.