Cleared Traditional

K162507 - Arzzt 3.5 / 4.5 Small & Large Fragments...

K162507 is an FDA 510(k) clearance for Arzzt 3.5 / 4.5 Small & Large Fragments..., manufactured by Truemed Group, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K162507 · Truemed Group, LLC · Orthopedic device
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Aug 2017
Decision
329d
Days
Class 2
Risk

K162507 is an FDA 510(k) clearance for the Arzzt 3.5 / 4.5 Small & Large Fragments 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 Truemed Group, LLC (Sprint, US). The FDA issued a Cleared decision on August 3, 2017 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Truemed Group, LLC devices

FDA 510(k) Submission Details - K162507

510(k) Number K162507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2016
Decision Date August 03, 2017
Days to Decision 329 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 122d · This submission: 329d
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 1016
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K162507.
EVOS Small Fragment Plating System
K172262 · Smith & Nephew, Inc. · Aug 2017
ARIX Ankle Fibula Hook Plate System
K170979 · Jeil Medical Corporation · Aug 2017
ARIX Foot System (2.3/2.8)
K170780 · Jeil Medical Corporation · Aug 2017
ARIX Ankle Distal Tibia System
K170313 · Jeil Medical Corporation · Jul 2017
ARIX Diaphysis System
K171285 · Jeil Medical Corporation · Jul 2017
In2Bones Fracture and Correction System
K170518 · In2bones USA, LLC · Jul 2017