Cleared Traditional

K141301 - MAXLOCK EXTREME ELBOW FRACTURE SYSTEM

K141301 is an FDA 510(k) clearance for MAXLOCK EXTREME ELBOW FRACTURE SYSTEM, manufactured by Orthohelix Surgical Designs, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K141301 · Orthohelix Surgical Designs, Inc. · Orthopedic device
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Jul 2014
Decision
53d
Days
Class 2
Risk

K141301 is an FDA 510(k) clearance for the MAXLOCK EXTREME ELBOW FRACTURE SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Orthohelix Surgical Designs, Inc. (Medina, US). The FDA issued a Cleared decision on July 11, 2014 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Orthohelix Surgical Designs, Inc. devices

FDA 510(k) Submission Details - K141301

510(k) Number K141301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2014
Decision Date July 11, 2014
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K141301.
PEDILOC FRAGMENT SYSTEM
K140431 · OrthoPediatrics Corp. · Jul 2014
LINOS MOH HAND PLATING SYSTEM
K141489 · KLS-Martin L.P. · Jul 2014
VARIAX ELBOW PLATING SYSTEM
K141677 · Stryker Trauma AG · Jul 2014
BIOFOAM BONE WEDGE
K140531 · Wrightmedicaltechnologyinc · Jul 2014
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
K141417 · Wrightmedicaltechnologyinc · Jul 2014
ARTHREX FRACTURE PLATES AND SCREWS
K141478 · Arthrex, Inc. · Jul 2014