Initia Total Hip System

Basic Information

• Brand Name: Initia Total Hip System
• Primary DI: 04547898304835
• Version / Model: GMH02-500023
• Catalog Number: GMH02-500023
• Company Name: KYOCERA CORPORATION
• Labeler DUNS: 690557624
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-21
• Public Version: 4
• Public Version Date: 2020-05-21
• Public Version Status: Update
• Public Device Record Key: 0bb62c1b-9b35-4dfa-80b4-ac5a2928197b

Device Description

INITIA STEM STD #6

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	888.3358	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33181	Metal-on-polyethylene total hip prosthesis	A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04547898304835	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Stem offset: 41mm
Device Size Text, specify			Neck length: 34mm
Device Size Text, specify			Stem length: 107mm
Device Size Text, specify			Taper: 12/14
Device Size Text, specify			Stem: Standard offset
Device Size Text, specify			Size: #6