Cleared Traditional

REL-K ARTIFICAL LIMB PROSTHESIS (K101859) - FDA 510(k) Clearance

Class I Physical Medicine device.

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

Submission Details

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.

Device Classification

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.