TiN Coated Humeral Head— 510(k) K191698

Clearance details

Applicant

Fx Shoulder USA, Inc.

Product code

Code KWT

Device class

Class 2

Regulation

21 CFR 888.3650

Advisory panel

Orthopedic

Date received

2019-06-25

Decision date

2020-07-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Dallas, TX, US

• K262173 — N22 Offset Humeral Head2026-09-08
• K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
• K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)2025-10-30
• K241944 — AGILON® XO Shoulder Replacement System2025-03-10
• K241817 — InSet Total Shoulder System2025-02-11

• K240278 — Full Wedge Lateralized and Augmented Baseplates2024-05-15
• K223801 — FX V135(TM) Shoulder Prosthesis2023-06-05
• K222936 — Humeris® 135 Shoulder System2022-11-07
• K213117 — FX V135 Shoulder Prosthesis2022-06-07
• K210790 — Lateralized and Augmented Baseplates2021-08-25

Injury

2,467

Other

2

Total

2,469

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →