Cleared Traditional

K130627 - SWING-OFF SCREW

K130627 is an FDA 510(k) clearance for SWING-OFF 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 166-day FDA review.

K130627 · Advanced Interventional Technology, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
166d
Days
Class 2
Risk

K130627 is an FDA 510(k) clearance for the SWING-OFF 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 August 21, 2013 after a review of 166 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.

FDA 510(k) Submission Details - K130627

510(k) Number K130627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2013
Decision Date August 21, 2013
Days to Decision 166 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
44d slower than avg
Panel avg: 122d · This submission: 166d
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 1052
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K130627.
FLOWER BONE SCREW SET
K132248 · Flower Orthopedics Corporation · Oct 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810 · Zimmer, Inc. · Sep 2013
SELF-COMPRESSIVE SCREW
K131471 · Neosteo · Aug 2013
KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
K131264 · Gebr. Brasseler GmbH & Co. KG · Jul 2013
HAMMERTOE CORRECTION SYSTEM
K130859 · Arthrosurface, Inc. · Jul 2013
JONES-FX FRACTURE SYSTEM
K131620 · Instratek, Inc. · Jul 2013