bioBLOCK® Subtalar Implant System

Basic Information

• Brand Name: bioBLOCK® Subtalar Implant System
• Primary DI: 10381780066552
• Version / Model: 040008
• Catalog Number: 040008
• 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: 2023-02-21
• Public Version Status: Update
• Public Device Record Key: 603a7c11-1f02-4c3b-a4a8-a33c9001adca
• Distribution End Date: 2026-12-31

Device Description

The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.

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
MJW	Prosthesis, Subtalar, Plug, Polymer	Orthopedic	888.3040	2
MBJ	Fastener, Fixation, Biodegradable, Hard Tissue	Unknown		3
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	M2480400080	HIBCC
Primary	10381780066552	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K051611	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8 mm dia x 15 mm L

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid contact with any objects that may damage the surface finish. Must be stored cool. Do not freeze.
• Type: Storage Environment Temperature
• Temperature Range: 0 – 43 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 0 – 110 Degrees Fahrenheit