Biocore9 Femoral Resurfacing Component

Basic Information

• Brand Name: Biocore9 Femoral Resurfacing Component
• Primary DI: 00810068850451
• Version / Model: Femoral Resurfacing Component - 51 mm
• Catalog Number: 01-03-0051
• Company Name: Biocore9, LLC
• Labeler DUNS: 093081548
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-27
• Public Version: 1
• Public Version Date: 2021-10-05
• Public Version Status: New
• Public Device Record Key: 045d2673-0fc1-4675-81bb-84b90139090d

Device Description

Biocore9 Femoral Resurfacing Head Component 51 mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXA	Prosthesis, Hip, Femoral, Resurfacing	Orthopedic	888.3400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64683	Resurfacing metallic femoral head prosthesis	An implantable, metallic, partial substitute for a disease-damaged hip joint intended to replace the articulating surface of the femoral head while preserving the natural femoral head and neck. Fixation devices for implantation (e.g., screws/bolts) may be included and implantation may be performed with or without bone cement. This device is commonly used for younger/active patients to avoid total hip replacements/revisions.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810068850451	GS1

Premarket Submissions

Submission Number	Supplement Number
K201219	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	51	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius