Cleared Special

GEO Bone Screw System (K202817) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K202817 · Gramercy Extremity Orthopedics, LLC · Orthopedic device
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Oct 2020
Decision
28d
Days
Class 2
Risk

K202817 is an FDA 510(k) clearance for the GEO Bone Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Gramercy Extremity Orthopedics, LLC (Richardson, US). The FDA issued a Cleared decision on October 22, 2020 after a review of 28 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 Gramercy Extremity Orthopedics, LLC devices

Submission Details

510(k) Number K202817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2020
Decision Date October 22, 2020
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 415
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K202817.
CREED™ Cannulated Screws
K200291 · Glw Medical, Inc. · Dec 2020
Monster Screw System
K203011 · Paragon 28, Inc. · Nov 2020
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System
K202589 · Medartis AG · Nov 2020
OsteoMed ExtremiFix Mini & Small Cannulated Screw System
K202680 · Osteomed, LLC · Oct 2020
Responsive Arthroscopy Interference Screw System
K202569 · Responsive Arthroscopy, LLC · Sep 2020
LTJ Screws and Washer
K200987 · Azurmeds, Inc. · Sep 2020