Cleared Traditional

K171365 - Arthrex Knee Systems

K171365 is an FDA 510(k) clearance for Arthrex Knee Systems, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code MBH cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K171365 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
182d
Days
Class 2
Risk

K171365 is an FDA 510(k) clearance for the Arthrex Knee Systems. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on November 7, 2017 after a review of 182 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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 Arthrex, Inc. devices

FDA 510(k) Submission Details - K171365

510(k) Number K171365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2017
Decision Date November 07, 2017
Days to Decision 182 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
60d slower than avg
Panel avg: 122d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBH Device Classification - Class 2, Special Controls

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 142
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K171365.
Triathlon Total Knee System
K173849 · Stryker Orthopaedics · Feb 2018
Zimmer Persona Personalized Knee System
K173417 · Zimmer, Inc. · Jan 2018
Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
K172634 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Nov 2017
EMPOWR Porous Knee System
K171991 · Encore Medical, L.P. · Oct 2017
BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell
K170288 · Microport Orthopedics, Inc. · Jun 2017
Klassic Femur, Porous, Klassic Tibial Baseplate, Porous
K162256 · Total Joint Orthopedics, Inc. · Oct 2016