Cleared Special

K190521 - Aequalis Ascend Flex Shoulder System

K190521 is an FDA 510(k) clearance for Aequalis Ascend Flex Shoulder System, manufactured by Tornier S.A.S.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Special 510(k) pathway after a 100-day FDA review.

K190521 · Tornier S.A.S. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
100d
Days
Class 2
Risk

K190521 is an FDA 510(k) clearance for the Aequalis Ascend Flex Shoulder System. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Tornier S.A.S. (Monbonnot Saint Martin, FR). The FDA issued a Cleared decision on June 12, 2019 after a review of 100 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K190521

510(k) Number K190521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date June 12, 2019
Days to Decision 100 days
Submission Type Special
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
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

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 191
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K190521.
Alliance Glenoid
K191814 · Zimmer, Inc. · Oct 2019
Materialise Glenoid Positioning System
K190286 · Materialise NV · Jul 2019
AEQUALIS FLEX REVIVE Shoulder System
K191318 · Tornier, Inc. · Jun 2019
AltiVate Reverse Humeral Stem, 48mm
K190290 · Encore Medical, L.P. · Apr 2019
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
K190521 · Aequalis Ascend Flex Shoulder System
Download PDF FDA Summary Tornier S.A.S.