Cleared Traditional

K222665 - Medline UNITE® Ankle Fusion Plating System

K222665 is an FDA 510(k) clearance for Medline UNITE Ankle Fusion Plating System, manufactured by Medline Industries, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K222665 · Medline Industries, Inc. · Orthopedic device
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Jan 2023
Decision
141d
Days
Class 2
Risk

K222665 is an FDA 510(k) clearance for the Medline UNITE® Ankle Fusion 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 Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on January 25, 2023 after a review of 141 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 Medline Industries, Inc. devices

FDA 510(k) Submission Details - K222665

510(k) Number K222665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2022
Decision Date January 25, 2023
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
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 1212
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K222665.
Tyber Medical Anatomical Plating System
K222465 · Tyber Medical, LLC · Mar 2023
Tibia and Fibula System
K213059 · Auxein Medical Private Limited · Jan 2023
Advanced Bone Plate
K221150 · Double Medical Technology, Inc. · Jan 2023
OIC Variable Angle Small Fragment Locking Plate System
K223118 · Orthopaedic Implant Company · Jan 2023
Anatomic Bone Plate
K221088 · Double Medical Technology, Inc. · Jan 2023
Treace Medical Concepts (TMC) Plating System
K221181 · Treace Medical Concepts, Inc. · Jan 2023