Cleared Traditional

K213827 - TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)

K213827 is an FDA 510(k) clearance for TITAN Total Shoulder System (TSS), manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K213827 · Smith & Nephew, Inc. · Orthopedic device
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Mar 2022
Decision
93d
Days
Class 2
Risk

K213827 is an FDA 510(k) clearance for the TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN.... Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Austin, US). The FDA issued a Cleared decision on March 11, 2022 after a review of 93 days - within the typical 510(k) review window.

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 Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K213827

510(k) Number K213827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2021
Decision Date March 11, 2022
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
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 K213827.
Catalyst EA Convertible Stemmed Shoulder
K222317 · Catalyst Orthoscience, Inc. · Nov 2022
AltiVate® Anatomic Shoulder AG e+™ with Markers
K213387 · Encore Medical, L.P. · Jul 2022
SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
K213785 · Limacorporate · May 2022
Exactech® Equinoxe® Laser Cage Glenoid
K212356 · Exactech, Inc. · Mar 2022
Comprehensive Humeral Fracture Positioning Sleeves
K212435 · Biomet, Inc. · Dec 2021
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
K210861 · Stryker GmbH · Sep 2021