32mm Femoral Head, 12/14 Taper, -3.5mm Offset

Basic Information

• Brand Name: 32mm Femoral Head, 12/14 Taper, -3.5mm Offset
• Primary DI: 00814703010217
• Version / Model: 3200.32.035
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• Labeler DUNS: 078416717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-21
• Public Version: 4
• Public Version Date: 2020-04-06
• Public Version Status: Update
• Public Device Record Key: 364dbf38-067b-4016-b47a-6941e348de15

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
MBL	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous	Orthopedic	888.3358	2
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented	Orthopedic	888.3360	2
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	888.3358	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33175	Metallic femoral head prosthesis	An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. 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 articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). 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	00814703010217	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100445	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			-3.5mm Offset

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