Toe MotionTM

Basic Information

• Brand Name: Toe MotionTM
• Primary DI: M5289P15PB02A0
• Version / Model: 9P15-PB02-A
• Catalog Number: 9P15-PB02-A
• Company Name: ARTHROSURFACE INCORPORATED
• Labeler DUNS: 144666109
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-15
• Public Version: 4
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 140f0b2e-93ca-460f-84b7-97ab18ba8989

Device Description

Modular Insert, 2.5mm Offset -02 (4.6mm thick)

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
LZJ	Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
61601	Total metatarsophalangeal joint prosthesis, modular	An implantable substitute for the metatarsophalangeal (MTP) joint of the foot (toe) intended to repair both articulating surfaces with matching metatarsal and phalangeal components, typically to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr)] and polymer materials and implantation may be performed with or without bone cement. Disposable instruments associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M5289P15PB02A0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132496	000