Cleared Special

K152711 - Parcus GFS Naked

K152711 is the FDA 510(k) clearance for Parcus GFS Naked by Parcus Medical, LLC. It is a Class 2 Orthopedic device (product code MBI) cleared through the Special 510(k) pathway after a 60-day FDA review.

K152711 · Parcus Medical, LLC · Orthopedic device
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Nov 2015
Decision
60d
Days
Class 2
Risk

K152711 is an FDA 510(k) clearance for the Parcus GFS Naked. 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 20, 2015 after a review of 60 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 K152711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2015
Decision Date November 20, 2015
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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

All 391
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K152711.
Adjustable Fixation Device
K153186 · Arthrocare Corp. · Jan 2016
SpeedLock Knotless Fixation System
K153313 · ArthroCare Corporation · Dec 2015
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors
K152566 · Smith & Nephew, Inc. · Dec 2015
JuggerKnot Soft Anchors
K150768 · Biomet Manufacturing Corp · Sep 2015
Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm
K150648 · Arthrex, Inc. · Aug 2015
MultiFIX® P Knotless Fixation Device
K151897 · ArthroCare Corporation · Aug 2015