Cleared Traditional

K142413 - TITAN Modular Total Shoulder System

K142413 is an FDA 510(k) clearance for TITAN Modular Total Shoulder System, 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 78-day FDA review.

K142413 · Ascension Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2014
Decision
78d
Days
Class 2
Risk

K142413 is an FDA 510(k) clearance for the TITAN Modular Total Shoulder System. 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 November 14, 2014 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ascension Orthopedics devices

FDA 510(k) Submission Details - K142413

510(k) Number K142413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2014
Decision Date November 14, 2014
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
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 Consultant

Integra LifeSciences Corporation
Frederic Testa

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K142413.
BLUEPRINT Patient Specific Instrumentation
K143374 · Tornier S.A.S. · Apr 2015
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
K142072 · Custom Orthopaedic Solutions, Inc. · Nov 2014
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System
K142403 · Zimmer GmbH · Nov 2014
SMR TT METAL BACK GLENOID
K133349 · Lima Corporate S.P.A. · Jun 2014
DEPUY GLOBAL UNITE SHOULDER SYSTEM
K133834 · Depuy(Ireland) · Apr 2014
EQUINOXE EXTRA SHORT HUMERAL HEAD
K140063 · Exactech, Inc. · Feb 2014