MBA™ Titanium Subtalar Implant System

Basic Information

• Brand Name: MBA™ Titanium Subtalar Implant System
• Primary DI: 10381780065494
• Version / Model: 050106
• Catalog Number: 050106
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 8
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 961f10db-1e00-4865-915f-5fc7b794a19a
• Distribution End Date: 2026-12-31

Device Description

The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. The implants are indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint.

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: Yes
• 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
Secondary	M2480501061	HIBCC
Primary	10381780065494	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K960692	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			.236 in dia x .59 in L

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.