Cleared Traditional

K191698 - TiN Coated Humeral Head

K191698 is an FDA 510(k) clearance for TiN Coated Humeral Head, manufactured by Fx Shoulder USA, Inc.. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 387-day FDA review.

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

FDA 510(k) Submission Details - K191698

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
Combination Product No
PCCP Authorized No
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.

KWT Device Classification - Class 2, Special Controls

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 59
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K191698.
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