Cleared Traditional

K031939 - BIO-EUROLIG INTERFERENCE SCREW

K031939 is an FDA 510(k) clearance for BIO-EUROLIG INTERFERENCE SCREW, 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 367-day FDA review.

K031939 · Fournitures Hospitalieres Industrie · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
367d
Days
Class 2
Risk

K031939 is an FDA 510(k) clearance for the BIO-EUROLIG INTERFERENCE SCREW. 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 June 24, 2004 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K031939

510(k) Number K031939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2003
Decision Date June 24, 2004
Days to Decision 367 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
245d slower than avg
Panel avg: 122d · This submission: 367d
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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K031939.
SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW
K040542 · Smith & Nephew, Inc. · Aug 2004
INION TRINION BIODEGRADABLE MENISCUS SCREW
K031714 · Inion , Ltd. · Aug 2004
LACTOSCREW SCREW ANCHOR
K033355 · Biomet Orthopedics, Inc. · Jun 2004
SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS
K040701 · Synthes (Usa) · Jun 2004
LITTLE GRAFTER SCREW
K040265 · Biocomposites, Ltd. · May 2004
MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
K040656 · Smith & Nephew, Inc. · May 2004