Cleared Traditional

K163710 - BePOD® EZ Weil Screws

K163710 is an FDA 510(k) clearance for BePOD EZ Weil 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 252-day FDA review.

K163710 · Fournitures Hospitalieres Industrie · Orthopedic device
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Sep 2017
Decision
252d
Days
Class 2
Risk

K163710 is an FDA 510(k) clearance for the BePOD® EZ Weil Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Fournitures Hospitalieres Industrie (Quimper Finistere, FR). The FDA issued a Cleared decision on September 8, 2017 after a review of 252 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 Fournitures Hospitalieres Industrie devices

FDA 510(k) Submission Details - K163710

510(k) Number K163710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2016
Decision Date September 08, 2017
Days to Decision 252 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
130d slower than avg
Panel avg: 122d · This submission: 252d
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 K163710.
MECRON Cannulated Screw System
K172213 · Merete GmbH · Oct 2017
Large Screws Range
K172596 · Newclip Technics · Oct 2017
BePOD® Foot Screws
K163148 · Fournitures Hospitalieres Industrie · Sep 2017
S4 Screw System™
K162171 · Subchondral Solutions · Sep 2017
ExsoMed ITN Cannulated Screw System
K171558 · Exsomed Holdings Company, LLC · Sep 2017
Medline UNITE® Snap-Off Screws
K170782 · Medline Industries, Inc. · Aug 2017