Cleared Traditional

K221333 - Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

K221333 is an FDA 510(k) clearance for Acumed Acutrak System- MR Conditional, manufactured by Acumed, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K221333 · Acumed, LLC · Orthopedic device
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Dec 2022
Decision
234d
Days
Class 2
Risk

K221333 is an FDA 510(k) clearance for the Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on December 29, 2022 after a review of 234 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 Acumed, LLC devices

FDA 510(k) Submission Details - K221333

510(k) Number K221333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2022
Decision Date December 29, 2022
Days to Decision 234 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
112d slower than avg
Panel avg: 122d · This submission: 234d
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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K221333.
CREED™ Cannulated Screws
K223847 · Glw, Inc. · Jan 2023
Metal Cannulated Screw
K221090 · Double Medical Technology, Inc. · Jan 2023
Haymaker® Screw System
K222799 · Orthocircle Spine D.B.A. OC Medical Devices · Jan 2023
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm
K221193 · OSSIO , Ltd. · Dec 2022
BRM TOOL Screws, BIOPLAN Subtalar Implant
K222820 · Brm Extremities · Dec 2022
Phantom Metatarsal Shortening System
K223184 · Paragon 28, Inc. · Dec 2022