Cleared Traditional

K101859 - REL-K ARTIFICAL LIMB PROSTHESIS

K101859 is an FDA 510(k) clearance for REL-K ARTIFICAL LIMB PROSTHESIS, manufactured by Rizzoli Ortopedica S.P.A.. The device is a Class 1 Physical Medicine device with product code ISY cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K101859 · Rizzoli Ortopedica S.P.A. · Physical Medicine device
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Oct 2010
Decision
103d
Days
Class 1
Risk

K101859 is an FDA 510(k) clearance for the REL-K ARTIFICAL LIMB PROSTHESIS. Classified as Joint, Knee, External Limb Component (product code ISY), Class I - General Controls.

Submitted by Rizzoli Ortopedica S.P.A. (Watertown, US). The FDA issued a Cleared decision on October 13, 2010 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3420 - the FDA physical medicine device 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Rizzoli Ortopedica S.P.A. devices

FDA 510(k) Submission Details - K101859

510(k) Number K101859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2010
Decision Date October 13, 2010
Days to Decision 103 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 115d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

ISY Device Classification - Class 1, General Controls

Product Code ISY Joint, Knee, External Limb Component
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.