HyProCure II Sinus Tarsi Stent Size 11

Basic Information

• Brand Name: HyProCure II Sinus Tarsi Stent Size 11
• Primary DI: M621HYPII110
• Version / Model: HYP II-11
• Catalog Number: HYP II-11
• Company Name: Gramedica
• Labeler DUNS: 828660345
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-04
• Public Version: 5
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 5f1784b7-0e78-4f77-9edc-f4b81107bd02

Device Description

HyProCure II Sinus Tarsi Implant Size 11. Indications: HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.

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: Yes
• 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
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40352	Subtalar implant, non-bioabsorbable	A device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M621HYPII110	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K142534	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			11mm