AccessGUDID - DEVICE: bioBLOCK® Subtalar Implant System (10381780066552)

GUDID

Device Identifier (DI) Information

Brand Name: bioBLOCK® Subtalar Implant System
Version or Model: 040008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 040008
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780066552
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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 not intended for arthrodesis/joint fusion. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MJW	Prosthesis, Subtalar, Plug, Polymer
MBJ	Fastener, Fixation, Biodegradable, Hard Tissue
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051611	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 603a7c11-1f02-4c3b-a4a8-a33c9001adca
Public Version Date: February 06, 2025
Public Version Number: 9
DI Record Publish Date: October 09, 2017