Cleared Traditional

K170910 - Medacta Anatomic Shoulder Prosthesis

K170910 is the FDA 510(k) clearance for Medacta Anatomic Shoulder Prosthesis by Medacta International S.A.. It is a Class 2 Orthopedic device (product code KWS) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K170910 · Medacta International S.A. · Orthopedic device
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Aug 2017
Decision
141d
Days
Class 2
Risk

K170910 is an FDA 510(k) clearance for the Medacta Anatomic Shoulder Prosthesis. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on August 16, 2017 after a review of 141 days - within the typical 510(k) review window.

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 Medacta International S.A. devices

Submission Details

510(k) Number K170910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2017
Decision Date August 16, 2017
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Mapi USA, Inc.
Roshana Ahmed, M.A., RAC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 153
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K170910.
Arthrex Shoulder System
K171841 · Arthrex, Inc. · Mar 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
Materialise Glenoid Positioning System
K170893 · Materialise NV · Jun 2017
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
K161863 · Stryker GmbH · Nov 2016
AltiVate Anatomic Shoulder System
K162024 · Encore Medical, L.P. · Nov 2016