Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head

Basic Information

• Brand Name: Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head
• Primary DI: 00814703017483
• Version / Model: 3301.00.105
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• Labeler DUNS: 078416717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-15
• Public Version: 1
• Public Version Date: 2021-12-23
• Public Version Status: New
• Public Device Record Key: 635de555-f1fa-4b99-bae0-2374de9066a8

Device Description

Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head, +10.5mm head length

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	888.3353	2
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	888.3358	2
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	888.3358	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59688	Femoral head/stem prosthesis adaptor	A sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814703017483	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K213580	000

Device Sizes

Type	Value	Unit	Text
Length	+10.5	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: The Klassic HD Hip System should be stored in a clean, dry location at room temperature