Cleared Traditional

K100123 - ACUMED WRIST ARTHRODESIS PLATE SYSTEM

K100123 is an FDA 510(k) clearance for ACUMED WRIST ARTHRODESIS PLATE SYSTEM, manufactured by Acumed, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K100123 · Acumed, LLC · Orthopedic device
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Oct 2010
Decision
264d
Days
Class 2
Risk

K100123 is an FDA 510(k) clearance for the ACUMED WRIST ARTHRODESIS PLATE 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 Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on October 6, 2010 after a review of 264 days - an extended review 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: 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 Acumed, LLC devices

FDA 510(k) Submission Details - K100123

510(k) Number K100123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2010
Decision Date October 06, 2010
Days to Decision 264 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
142d slower than avg
Panel avg: 122d · This submission: 264d
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 1269
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K100123.
ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW
K102429 · Wrightmedicaltechnologyinc · Nov 2010
CLAVICLE LOCKING PLATE SYSTEM
K100944 · Newclip Technics · Oct 2010
CONTOURS VSP III VOLAR PLATING SYSTEM
K101936 · Orthofix, Inc. · Oct 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
K102156 · Orthohelix Surgical Designs, Inc. · Sep 2010
MINI MAXLOCK EXTREME PLATING SYSTEM
K101962 · Orthohelix Surgical Designs, Inc. · Sep 2010
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
K100776 · Synthes (Usa) · Aug 2010