Cleared Traditional

K142413 - TITAN Modular Total Shoulder System (FDA 510(k) Clearance)

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

K142413 · Ascension Orthopedics · Orthopedic device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 116d · This submission: 78d
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 K142413.
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