Cleared Special

K151293 - Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis

K151293 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 132-day FDA review.

K151293 · Tornier S.A.S. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
132d
Days
Class 2
Risk

K151293 is an FDA 510(k) clearance for the Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis. 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 September 24, 2015 after a review of 132 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 - K151293

510(k) Number K151293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2015
Decision Date September 24, 2015
Days to Decision 132 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
10d slower than avg
Panel avg: 122d · This submission: 132d
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 K151293.
Remedy® Shoulder Spacer
K152267 · Osteoremedies, LLC · Dec 2015
Arthrex Univers Apex, Size 5 Stem
K153115 · Arthrex, Inc. · Nov 2015
Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)
K151500 · Custom Orthopaedic Solutions · Oct 2015
SMR Modular Glenoid
K143256 · Lima Corporate S.P.A. · May 2015
Aequalis PerFORM+ Shoulder System
K150583 · Tornier, Inc. · Apr 2015
BLUEPRINT Patient Specific Instrumentation
K143374 · Tornier S.A.S. · Apr 2015
K151293 · Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
Download PDF FDA Summary Tornier S.A.S.