Cleared Traditional

K130954 - ARS SCREW

Also marketed or referenced as:
SLANT SCREW

K130954 is an FDA 510(k) clearance for ARS SCREW, manufactured by Advanced Interventional Technology, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K130954 · Advanced Interventional Technology, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
56d
Days
Class 2
Risk

K130954 is an FDA 510(k) clearance for the ARS SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Advanced Interventional Technology, LLC (Derwood, US). The FDA issued a Cleared decision on May 31, 2013 after a review of 56 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 Advanced Interventional Technology, LLC devices

FDA 510(k) Submission Details - K130954

510(k) Number K130954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2013
Decision Date May 31, 2013
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 747
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K130954.
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810 · Zimmer, Inc. · Sep 2013
HAMMERTOE CORRECTION SYSTEM
K130859 · Arthrosurface, Inc. · Jul 2013
MEDLINE CANNULATED SCREW
K130319 · Medline Industries, Inc. · May 2013
MAXTORQUE SCREW SYSTEM
K131324 · Orthohelix Surgical Designs, Inc. · May 2013
AAP CANNULATED SCREW 2.0
K130590 · Aap Implantate AG · Apr 2013
EXTREMITY MEDICAL IP FUSION SYSTEM
K130120 · Extremity Medical, LLC · Apr 2013