Echo® Bi-Metric® Hip System

Basic Information

• Brand Name: Echo® Bi-Metric® Hip System
• Primary DI: 00887868273995
• Version / Model: 192516
• Catalog Number: 192516
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-13
• Public Version: 2
• Public Version Date: 2020-04-13
• Public Version Status: Update
• Public Device Record Key: 67efe6d4-94e3-485a-ae5f-711dfd55646d

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: No

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
MAY	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish	Orthopedic	888.3353	2
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	Orthopedic	888.3390	2
KWL	Prosthesis, hip, hemi-, femoral, metal	Orthopedic	888.3360	2
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	Orthopedic	888.3350	2
MEH	Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate	Orthopedic	888.3353	2
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented	Orthopedic	888.3360	2
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer	Orthopedic	888.3310	2
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	Orthopedic	888.3330	3

GMDN Terms

Code	Name	Definition	Implantable	Status
38155	Press-fit femoral stem prosthesis	A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887868273995	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070274	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			16 Size 160 mm Type I Taper