Cleared Traditional

K161904 - GEO Bone Screw System

K161904 is an FDA 510(k) clearance for GEO Bone Screw System, manufactured by Gramercy Extremity Orthopeidics, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K161904 · Gramercy Extremity Orthopeidics, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
191d
Days
Class 2
Risk

K161904 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 Orthopeidics, LLC (Richardson, US). The FDA issued a Cleared decision on January 18, 2017 after a review of 191 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Gramercy Extremity Orthopeidics, LLC devices

FDA 510(k) Submission Details - K161904

510(k) Number K161904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2016
Decision Date January 18, 2017
Days to Decision 191 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 122d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 735
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K161904.
BePOD Cannulated Arthrodesis Screws
K170040 · Fournitures Hospitalieres Industrie · Apr 2017
ToeMATE® Hammertoe Correction System
K170350 · Arthrosurface, Inc. · Mar 2017
DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
K161616 · Synthes USA Products, LLC · Feb 2017
KLS Martin Cannulated Headless Screws
K161259 · KLS-Martin L.P. · Dec 2016
Tyber Medical BioTy® Nanotopography Trauma Screw
K161597 · Tyber Medical, LLC · Nov 2016
I.B.S. 2.0 Osteosynthesis screw
K160174 · In2bones Sas · Oct 2016