28mm BIOLOX delta Ceramic Femoral Head, 12/14 taper

Basic Information

• Brand Name: 28mm BIOLOX delta Ceramic Femoral Head, 12/14 taper
• Primary DI: 00814703014932
• Version / Model: 3203.28.000
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• Labeler DUNS: 078416717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-12
• Public Version: 2
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: 6c0a8a28-3824-4f12-b72c-d2e16d80775e

Device Description

28mm BIOLOX delta Ceramic Femoral Head, 12/14 taper, +0mm 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
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	Orthopedic	888.3353	2
MBL	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous	Orthopedic	888.3358	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38156	Ceramic femoral head prosthesis	An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814703014932	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180929	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			+0mm head length

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