Cleared Special

K162198 - GFS Ultimate

K162198 is the FDA 510(k) clearance for GFS Ultimate by Parcus Medical, LLC. It is a Class 2 Orthopedic device (product code MBI) cleared through the Special 510(k) pathway after a 105-day FDA review.

K162198 · Parcus Medical, LLC · Orthopedic device
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Nov 2016
Decision
105d
Days
Class 2
Risk

K162198 is an FDA 510(k) clearance for the GFS Ultimate. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Parcus Medical, LLC (Sarasota, US). The FDA issued a Cleared decision on November 18, 2016 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Parcus Medical, LLC devices

Submission Details

510(k) Number K162198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2016
Decision Date November 18, 2016
Days to Decision 105 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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.

Regulatory Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

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