Cleared Traditional

K181555 - Arthrex Fracture Adapter Hemi Shoulder Prosthesis

K181555 is an FDA 510(k) clearance for Arthrex Fracture Adapter Hemi Shoulder ..., 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 191-day FDA review.

K181555 · Arthrex, Inc. · Orthopedic device
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Dec 2018
Decision
191d
Days
Class 2
Risk

K181555 is an FDA 510(k) clearance for the Arthrex Fracture Adapter Hemi Shoulder Prosthesis. 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 December 21, 2018 after a review of 191 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 - K181555

510(k) Number K181555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2018
Decision Date December 21, 2018
Days to Decision 191 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
69d slower than avg
Panel avg: 122d · This submission: 191d
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 K181555.
Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads
K182799 · Arthrex, Inc. · Mar 2019
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
K183039 · Stryker GmbH · Feb 2019
SMR Lateralized Connectors with screws
K183042 · Lima Corporate S.P.A. · Jan 2019
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
Arthrex Shoulder System
K171841 · Arthrex, Inc. · Mar 2018