B-P TOTAL HIP SYSTEM

Basic Information

• Brand Name: B-P TOTAL HIP SYSTEM
• Primary DI: 00814193023957
• Version / Model: 01-16-0212
• Catalog Number: 01-16-0212
• Company Name: Synovo Production
• Labeler DUNS: 061486164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-17
• Public Version: 5
• Public Version Date: 2024-02-22
• Public Version Status: Update
• Public Device Record Key: 636d8b59-717d-462f-8a05-902f2408bcf9

Device Description

B-P MODULAR EXTENSION W/ULTRACOAT - 12 MM X 50 MM

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
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	888.3350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34162	Bipolar humeral head outer component	An implantable, hemisphere-shaped component of a bipolar partial shoulder prosthesis designed to interface with the glenoid fossa on its outer surface where it freely rotates, and interface with a humeral head prosthesis on its inner surface where it allows free rotation of the head. It is typically composed of an outer metal shell and an inner polyethylene (PE) liner.	Yes	Active
33695	Bipolar femoral head outer component, hemiarthroplasty	An implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.	Yes	Active
33715	Ceramic-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 ceramic-on-polyethylene or cross-linked polyethylene (PE) 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	00814193023957	GS1

Premarket Submissions

Submission Number	Supplement Number
K905262	000

Device Sizes

Type	Value	Unit	Text
Length	50	Millimeter
Width	12	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius