Cleared Traditional

K122698 - AEQUALIS ASCEND FLEX SHOULDER SYSTEM

K122698 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 Traditional 510(k) pathway after a 126-day FDA review.

K122698 · Tornier S.A.S. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2013
Decision
126d
Days
Class 2
Risk

K122698 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. (Bloomington, US). The FDA issued a Cleared decision on January 8, 2013 after a review of 126 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 Tornier S.A.S. devices

FDA 510(k) Submission Details - K122698

510(k) Number K122698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2012
Decision Date January 08, 2013
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
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 183
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K122698.
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
K130129 · Arthrex, Inc. · May 2013
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
K123122 · Cleveland Clinic · Apr 2013
TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+
K123982 · Encore Medical, L.P. · Jan 2013
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
K121220 · Exactech, Inc. · Nov 2012
ASCEND SHOULDER SYSTEM
K121493 · Tornier, Inc. · Jun 2012
ASCEND SHOULDER SYSTEM
K120794 · Tornier, Inc. · Apr 2012