Cleared Traditional

K191698 - TiN Coated Humeral Head (FDA 510(k) Clearance)

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

K191698 · Fx Shoulder USA, Inc. · Orthopedic device
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Jul 2020
Decision
387d
Days
Class 2
Risk

K191698 is an FDA 510(k) clearance for the TiN Coated Humeral Head. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Fx Shoulder USA, Inc. (Dallas, US). The FDA issued a Cleared decision on July 16, 2020 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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. Elevated predicate reliance profile. 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 Fx Shoulder USA, Inc. devices

Submission Details

510(k) Number K191698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2019
Decision Date July 16, 2020
Days to Decision 387 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
265d slower than avg
Panel avg: 122d · This submission: 387d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 70
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K191698.
Equinoxe® Humeral Reconstruction Prosthesis
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Tornier Humeral Reconstruction System Max (Tornier HRS Max)
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AGILON® XO Shoulder Replacement System
K241944 · Implantcast GmbH · Mar 2025
InSet Total Shoulder System
K241817 · Shoulder Innovations, Inc. · Feb 2025
AGILON® XO Shoulder Replacement System
K231657 · Implantcast GmbH · Feb 2024
Comprehensive Segmental Revision System(SRS)
K223631 · Biomet Orthopedics · Jul 2023