Cleared Traditional

K171841 - Arthrex Shoulder System

K171841 is an FDA 510(k) clearance for Arthrex Shoulder System, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K171841 · Arthrex, Inc. · Orthopedic device
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Mar 2018
Decision
282d
Days
Class 2
Risk

K171841 is an FDA 510(k) clearance for the Arthrex Shoulder System. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on March 29, 2018 after a review of 282 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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 - K171841

510(k) Number K171841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2017
Decision Date March 29, 2018
Days to Decision 282 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
160d slower than avg
Panel avg: 122d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 184
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K171841.
Arthrex Fracture Adapter Hemi Shoulder Prosthesis
K181555 · Arthrex, Inc. · Dec 2018
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
K181742 · Stryker GmbH · Sep 2018
Aequalis Flex Revive Shoulder System
K181420 · Tornier, Inc. · Sep 2018
Materialise Glenoid Positioning System
K172054 · Materialise NV · Nov 2017
AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert
K172351 · Encore Medical, L.P. · Oct 2017
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
K172210 · Stryker Trauma AG · Oct 2017