Cleared Special

K151293 - Aequalis Ascend Flex Shoulder System

K151293 is the FDA 510(k) clearance for Aequalis Ascend Flex Shoulder System by Tornier S.A.S.. It is a Class 2 Orthopedic device (product code KWS) cleared through the Special 510(k) pathway after a 132-day FDA review.

K151293 · Tornier S.A.S. · Orthopedic device
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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.

View all Tornier S.A.S. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 122d · This submission: 132d
Pathway characteristics
Modification to existing cleared device.

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

All 153
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