Chrysalis Intelligence · Sponsors · Fx Shoulder USA, Inc.

Fx Shoulder USA, Inc.

Dallas, TX, US · 10 510(k) clearances

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Total clearances
10
2020-02-21 → 2024-05-15
Last 12 months
0
Product codes
3
Most recent
2024-05-15
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PHX Shoulder Prosthesis, Reverse Configuration Class II Orthopedic 8 2024-05-15
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Class II Orthopedic 1 2021-02-16
KWT — — — 1 2020-07-16
Filings

All 510(k) clearances (10)

Date K-number Device Code Class Specialty
2024-05-15 K240278 Full Wedge Lateralized and Augmented Baseplates PHX Class II Orthopedic
2023-06-05 K223801 FX V135(TM) Shoulder Prosthesis PHX Class II Orthopedic
2022-11-07 K222936 Humeris® 135 Shoulder System PHX Class II Orthopedic
2022-06-07 K213117 FX V135 Shoulder Prosthesis PHX Class II Orthopedic
2021-08-25 K210790 Lateralized and Augmented Baseplates PHX Class II Orthopedic
2021-02-16 K201391 Easytech® Anatomical Shoulder System PKC Class II Orthopedic
2020-07-16 K191698 TiN Coated Humeral Head KWT — —
2020-07-15 K191146 Humelock TiN Coated Glenosphere PHX Class II Orthopedic
2020-04-29 K193394 Humeral Cup Stability & Humeral Cup 135/145o Stability PHX Class II Orthopedic
2020-02-21 K192799 Glenoid Baseplate with Screw PHX Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence