Cleared Traditional

K152047 - INTEGRA TITAN Modular Total Shoulder Sy...

K152047 is the FDA 510(k) clearance for INTEGRA TITAN Modular Total Shoulder Sy... by Ascension Orthopedics. It is a Class 2 Orthopedic device (product code KWS) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K152047 · Ascension Orthopedics · Orthopedic device
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Dec 2015
Decision
153d
Days
Class 2
Risk

K152047 is an FDA 510(k) clearance for the INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Ascension Orthopedics (Austin, US). The FDA issued a Cleared decision on December 23, 2015 after a review of 153 days - an extended review cycle.

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 Ascension Orthopedics devices

Submission Details

510(k) Number K152047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2015
Decision Date December 23, 2015
Days to Decision 153 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 122d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K152047.
Materialise Glenoid Positioning System
K153602 · Materialise NV · Apr 2016
SMR 3-Pegs Glenoids
K153722 · Lima Corporate S.P.A. · Apr 2016
Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System
K160085 · Zimmer GmbH · Mar 2016
Arthrex Univers Apex, Size 5 Stem
K153115 · Arthrex, Inc. · Nov 2015
SMR Modular Glenoid
K143256 · Lima Corporate S.P.A. · May 2015
Aequalis PerFORM+ Shoulder System
K150583 · Tornier, Inc. · Apr 2015