Cleared Traditional

K152047 - INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152047 · Ascension Orthopedics · Orthopedic device
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.

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
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 116d · 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 14
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K152047.
Catalyst F1x Shoulder System
K252418 · Catalyst Orthoscience, Inc. · Nov 2025
AETOS Shoulder System Meta Humeral Prosthesis Size 0
K252416 · Smith & Nephew, Inc. · Oct 2025
MyShoulder Planner (5.3SSWPL)
K241292 · Medacta International S.A. · Jan 2025
Arthrex Univers Apex OptiFit Humeral Stem
K230513 · Arthrex, Inc. · Sep 2023
AltiVate® Anatomic Shoulder AG e+™ with Markers
K222592 · Encore Medical, L.P. · Jun 2023
AETOS Shoulder System
K230572 · Smith & Nephew, Inc. · Jun 2023