Cleared Traditional

K181820 - Medline Unite Mini Plates and Screws

K181820 is the FDA 510(k) clearance for Medline Unite Mini Plates and Screws by Medline Industries, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K181820 · Medline Industries, Inc. · Orthopedic device
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Nov 2018
Decision
115d
Days
Class 2
Risk

K181820 is an FDA 510(k) clearance for the Medline Unite Mini Plates and Screws. 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 November 1, 2018 after a review of 115 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

Submission Details

510(k) Number K181820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2018
Decision Date November 01, 2018
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 914
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K181820.
AdvantageRib Anterior System
K182179 · Sig Medical Corp. · Nov 2018
Stratum™ Foot Plating System
K182201 · Nextremity Solutions, Inc. · Nov 2018
DePuy Synthes Trauma Orthopedic Plates and Screws
K180310 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · Nov 2018
AOS Calcaneal Plating System
K182466 · Advanced Orthopaedic Solutions · Oct 2018
ANTHEM Fracture System
K180554 · Globus Medical, Inc. · Oct 2018
Titanium TomoFix Medial High Tibia Plate Anatomical
K180213 · Synthes USA Products, LLC · Oct 2018