Cleared Traditional

K070617 - CANNULATED SCREW

K070617 is an FDA 510(k) clearance for CANNULATED 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 101-day FDA review.

K070617 · Fournitures Hospitalieres Industrie · Orthopedic device
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Jun 2007
Decision
101d
Days
Class 2
Risk

K070617 is an FDA 510(k) clearance for the CANNULATED 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 14, 2007 after a review of 101 days - within the typical 510(k) review window.

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 - K070617

510(k) Number K070617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2007
Decision Date June 14, 2007
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
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 K070617.
GRAFTLOCK SCREW, ST SCREW
K071952 · Biocomposites, Ltd. · Aug 2007
HEALIX ANCHOR
K071481 · Depuy Mitek, A Johnson & Johnson Company · Aug 2007
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW
K071177 · Arthrex, Inc. · Jun 2007
MODIFICATION TO BILOK SCREW
K071091 · Biocomposites, Ltd. · May 2007
MODIFICATION TO BILOK ST SCREW
K071115 · Biocomposites, Ltd. · May 2007
ALLOFIX PUSH-IN ANCHOR
K070347 · Musculoskeletal Transplant Foundation · May 2007