B-P TOTAL KNEE SYSTEM

Basic Information

• Brand Name: B-P TOTAL KNEE SYSTEM
• Primary DI: 00814193020437
• Version / Model: 04-31-2304
• Catalog Number: 04-31-2304
• 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: 4
• Public Version Date: 2024-02-22
• Public Version Status: Update
• Public Device Record Key: 0a980d3a-a083-476c-a216-17ab8c9dfcbc

Device Description

B-P KNEE NARROW FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT, LEFT, SIZE 4

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
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	888.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33664	Cruciate-retaining total knee prosthesis	A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative (e.g., arthritic) joint [total knee arthroplasty (TKA)]; it is designed to be implanted with retention of the posterior cruciate ligament. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE). The device may be implanted with or without bone cement and is typically used in cases where bone stock is good and supporting ligaments provide adequate stability.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814193020437	GS1

Premarket Submissions

Submission Number	Supplement Number
K012702	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			SIZE 4, LEFT

Storage Conditions

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