Cleared Traditional

K163361 - ANTHEM™ Fracture System

K163361 is an FDA 510(k) clearance for ANTHEM Fracture System, manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K163361 · Globus Medical, Inc. · Orthopedic device
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Apr 2017
Decision
128d
Days
Class 2
Risk

K163361 is an FDA 510(k) clearance for the ANTHEM™ Fracture 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 Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on April 7, 2017 after a review of 128 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 Globus Medical, Inc. devices

FDA 510(k) Submission Details - K163361

510(k) Number K163361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2016
Decision Date April 07, 2017
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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 1235
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K163361.
EVOS Small Fragment Plating System
K170887 · Smith & Nephew, Inc. · Apr 2017
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System
K163383 · Greens Surgicals Pvt. , Ltd. · Apr 2017
Additive Orthopaedics Locking Lattice Plate
K170214 · Additive Orthopaedics, LLC · Apr 2017
Alians Clavicle range
K170310 · Newclip Technics · Mar 2017
NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System
K163425 · Narang Medical USA Corporation · Mar 2017
Olecranon Plating System
K162898 · Miami Device Solutions, LLC · Mar 2017