Cleared Traditional

K101962 - MINI MAXLOCK EXTREME PLATING SYSTEM

K101962 is an FDA 510(k) clearance for MINI MAXLOCK EXTREME PLATING 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 76-day FDA review.

K101962 · Orthohelix Surgical Designs, Inc. · Orthopedic device
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Sep 2010
Decision
76d
Days
Class 2
Risk

K101962 is an FDA 510(k) clearance for the MINI MAXLOCK EXTREME PLATING 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 September 27, 2010 after a review of 76 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 - K101962

510(k) Number K101962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2010
Decision Date September 27, 2010
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 K101962.
CONTOURS VSP III VOLAR PLATING SYSTEM
K101936 · Orthofix, Inc. · Oct 2010
ACUMED WRIST ARTHRODESIS PLATE SYSTEM
K100123 · Acumed, LLC · Oct 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
K102156 · Orthohelix Surgical Designs, Inc. · Sep 2010
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
K100776 · Synthes (Usa) · Aug 2010
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22
K101240 · DePuy Orthopaedics, Inc. · Jul 2010
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708
K101421 · DePuy Orthopaedics, Inc. · Jun 2010