Mallory-Head® Calcar Hip System 11-105007

GUDID 00889024703346

Biomet Orthopedics, LLC

Uncoated hip femur prosthesis, modular

• Primary Device ID: 00889024703346
• NIH Device Record Key: 58e5a36d-b27f-44ab-99fd-1961caf2aa8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mallory-Head® Calcar Hip System
• Version Model Number: 11-105007
• Catalog Number: 11-105007
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024703346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031693

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS 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: 2026-02-11
• Device Publish Date: 2026-02-03

Devices Manufactured by Biomet Orthopedics, LLC

• 00880304009615 - BMP CABLE CUTTER: 2026-02-11
• 00880304387676 - OPEN END CUTTER: 2026-02-11
• 00887868000027 - TWIST DRILL BIT: 2026-02-11
• 00887868000645 - CALIBRATED TWIST DRILL: 2026-02-11
• 00887868048265 - EASYOUT: 2026-02-11
• 00887868048319 - EXTRACTION BOLT: 2026-02-11
• 00887868048326 - EXTRACTION BOLT: 2026-02-11
• 00887868048333 - EXTRACTION BOLT: 2026-02-11