Cleared Traditional

K142057 - INFIX CANNULATED SCREW SYSTEM

K142057 is an FDA 510(k) clearance for INFIX CANNULATED SCREW SYSTEM, manufactured by Infix Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K142057 · Infix Medical, LLC · Orthopedic device
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Jan 2015
Decision
168d
Days
Class 2
Risk

K142057 is an FDA 510(k) clearance for the INFIX CANNULATED SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Infix Medical, LLC (Gulf Breeze, US). The FDA issued a Cleared decision on January 13, 2015 after a review of 168 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 Infix Medical, LLC devices

FDA 510(k) Submission Details - K142057

510(k) Number K142057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2014
Decision Date January 13, 2015
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
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 742
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K142057.
Extremity Medical Calcaneal Osteotomy Device
K143402 · Extremity Medical, LLC · Feb 2015
Cannulated Screw System
K143460 · Wrightmedicaltechnologyinc · Jan 2015
Arthrex Low Profile Screws
K143614 · Arthrex, Inc. · Jan 2015
Headless Compression Screw System
K143624 · Skeletal Dynamics, LLC · Jan 2015
3.Omm Biomet Cannulated Screw System
K143188 · Biomet Manufacturing Corp · Dec 2014
AIS Odontoid Fracture Fixation System
K142707 · Aesculap Implant System, Inc. · Dec 2014