B-P TOTAL HIP SYSTEM

Basic Information

• Brand Name: B-P TOTAL HIP SYSTEM
• Primary DI: 00814193022981
• Version / Model: 01-03-0032
• Catalog Number: 01-03-0032
• 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: 02448c4d-2109-4367-b632-beeba1e46fd5

Device Description

B-P HIP FEMORAL RESURFACING CUP W/BIOCOAT & W/ULTRACOAT - 32.5 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
KXA	Prosthesis, Hip, Femoral, Resurfacing	Orthopedic	888.3400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33717	Resurfacing metallic hip prosthesis	An implantable partial substitute for a disease-damaged hip joint intended to replace the articulating surfaces of the hip while preserving the natural femoral head and neck. It consists of a metallic femoral cap component, that is placed over (resurfaces) a surgically-prepared femoral head, and a metallic acetabular component; that is, both components are supplied together. Fixation devices for implantation (e.g., screws/bolts) may be included and implantation may be performed with or without bone cement. This device is commonly used for younger/active patients to avoid total hip replacements/revisions.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814193022981	GS1

Premarket Submissions

Submission Number	Supplement Number
K904870	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	32.5	Millimeter

Storage Conditions

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