Cleared Traditional

K170040 - BePOD Cannulated Arthrodesis Screws

K170040 is an FDA 510(k) clearance for BePOD Cannulated Arthrodesis Screws, manufactured by Fournitures Hospitalieres Industrie. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K170040 · Fournitures Hospitalieres Industrie · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
89d
Days
Class 2
Risk

K170040 is an FDA 510(k) clearance for the BePOD Cannulated Arthrodesis Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Fournitures Hospitalieres Industrie (Quimper, FR). The FDA issued a Cleared decision on April 4, 2017 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fournitures Hospitalieres Industrie devices

FDA 510(k) Submission Details - K170040

510(k) Number K170040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2017
Decision Date April 04, 2017
Days to Decision 89 days
Submission Type Traditional
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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K170040.
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OrthoSolutions 'System26' Bone Screws
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EPIC Extremity Snap-Off Screw
K163038 · Epic Extremity, LLC · Feb 2017