Cleared Traditional

K210750 - Acumed Clavicle Hook Plating System

K210750 is an FDA 510(k) clearance for Acumed Clavicle Hook Plating 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 125-day FDA review.

K210750 · Acumed, LLC · Orthopedic device
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Jul 2021
Decision
125d
Days
Class 2
Risk

K210750 is an FDA 510(k) clearance for the Acumed Clavicle Hook 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 Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on July 15, 2021 after a review of 125 days - within the typical 510(k) review window.

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 - K210750

510(k) Number K210750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2021
Decision Date July 15, 2021
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
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 K210750.
FINE Osteotomy
K211646 · Bodycad Laboratories, Inc. · Jul 2021
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System
K210016 · Integra LifeSciences Corporation · Jul 2021
Avanti Orthopaedics Ulnar Shortening System
K211592 · Avanti Orthopaedics, Inc. · Jul 2021
TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
K200575 · Truemed Group, LLC · Jul 2021
Smith & Nephew Plates and Screws
K210837 · Smith & Nephew, Inc. · Jun 2021
Valkyrie Thoracic Fixation System
K211695 · Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · Jun 2021