Cleared Traditional

K152047 - INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid

K152047 is an FDA 510(k) clearance for INTEGRA TITAN Modular Total Shoulder Sy..., manufactured by Ascension Orthopedics. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K152047

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
Combination Product No
PCCP Authorized No
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.

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 K152047.
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
SmartBase for Arthrex Glenoid IRIS
K153215 · Custom Orthopaedic Solutions, Inc. · Feb 2016
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