Cleared Traditional

K221333 - Acumed Acutrak System- MR Conditional

K221333 is the FDA 510(k) clearance for Acumed Acutrak System- MR Conditional by Acumed, LLC. It is a Class 2 Orthopedic device (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

Submission Details

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.

Device Classification

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 552
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