Humelock Cemented Shoulder System

GUDID 03701037300510

OFFSET HEAD CoCr 50x20

FX SOLUTIONS

Stem-fixed humeral head prosthesis

• Primary Device ID: 03701037300510
• NIH Device Record Key: 0d847b9a-1d2f-44b0-828d-d0b7381d998e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humelock Cemented Shoulder System
• Version Model Number: 106-5000
• Company DUNS: 263076196
• Company Name: FX SOLUTIONS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701037300510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111097

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-30
• Device Publish Date: 2024-01-22

Devices Manufactured by FX SOLUTIONS

• 03701037311776 - Humelock II: 2025-08-11 BONE GRAFT CUTTER
• 03701037311783 - Humelock II: 2025-08-11 BONE GRAFT CUTTER
• 03701037311790 - Humelock II: 2025-08-11 BONE GRAFT CUTTER
• 03701037311806 - Humelock II: 2025-08-11 BONE GRAFT CUTTER
• 03701037311813 - Humelock II: 2025-08-11 BONE GRAFT CUTTER
• 03701037316450 - FX V135: 2025-08-11 STABILITY TRIAL CUP 135-145° FOR IMPLANT Ø36 +3
• 03701037321133 - Humelock Reversed: 2025-08-11 HOLE SAW Ø26mm H14mm WITH DRILL Ø8mm/HUDSON
• 03701037321140 - Humelock Reversed Shoulder: 2025-08-11 STARTER Ø06mm / HUDSON