Cleared Traditional

Stratum™ Foot Plating System (K182201) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182201 · Nextremity Solutions, Inc. · Orthopedic device
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Nov 2018
Decision
94d
Days
Class 2
Risk

K182201 is an FDA 510(k) clearance for the Stratum™ Foot 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 Nextremity Solutions, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 16, 2018 after a review of 94 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 Nextremity Solutions, Inc. devices

Submission Details

510(k) Number K182201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2018
Decision Date November 16, 2018
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
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 697
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K182201.
Distal Radius Plating System
K182810 · Miami Device Solutions, LLC · Dec 2018
ARIX Sternal System
K181806 · Jeil Medical Corporation · Nov 2018
AdvantageRib Anterior System
K182179 · Sig Medical Corp. · Nov 2018
DePuy Synthes Trauma Orthopedic Plates and Screws
K180310 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · Nov 2018
Medline Unite Mini Plates and Screws
K181820 · Medline Industries, Inc. · Nov 2018
AOS Calcaneal Plating System
K182466 · Advanced Orthopaedic Solutions · Oct 2018