PRELUDE PATELLO-FEMORAL SYSTEM

Basic Information

• Brand Name: PRELUDE PATELLO-FEMORAL SYSTEM
• Primary DI: 00880304564350
• Version / Model: 010001768
• Catalog Number: 010001768
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-26
• Public Version: 6
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 9049c5a2-6c1b-4efe-a5aa-30db8a9c9666

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRR	PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45114	Bone-resection orthopaedic reamer, reusable	An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00880304564350	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K143543	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			31MM REAMER