Cleared Traditional

K131559 - MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES

K131559 is an FDA 510(k) clearance for MATCH POINT SYSTEM(TM), manufactured by Materialise NV. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K131559 · Materialise NV · Orthopedic device
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Sep 2013
Decision
120d
Days
Class 2
Risk

K131559 is an FDA 510(k) clearance for the MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on September 27, 2013 after a review of 120 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 Materialise NV devices

FDA 510(k) Submission Details - K131559

510(k) Number K131559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2013
Decision Date September 27, 2013
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
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 185
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K131559.
EQUINOXE EXTRA SHORT HUMERAL HEAD
K140063 · Exactech, Inc. · Feb 2014
DUOCENTRIC REVERSED SHOULDER PROSTHESIS
K133462 · Aston Medical · Feb 2014
REVERSE SHOULDER PROSTHESIS MONOBLOCK
K130048 · Encore Medical, L.P. · Oct 2013
ARTHREX UNIVERS APEX
K131633 · Arthrex, Inc. · Sep 2013
SEVIIN FRACTURE SHOULDER
K131277 · Ingen Orthopedics, LLC · Aug 2013
CAS PSI SHOULDER
K131129 · Zimmer Cas · Aug 2013