bioBLOCK® Subtalar Implant System

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: bioBLOCK® Subtalar Implant System FDA UDI
Generic Name: Subtalar implant, non-bioabsorbable FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 040009 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: 040009 FDA UDI
Primary DI / UDI-DI: 10381780066569 FDA UDI
510(k) Number: K051611 FDA UDI
FDA Product Code: HWC FDA UDI
MBJ FDA UDI
MJW FDA UDI
GMDN Term: Subtalar implant, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Subtalar implant, non-bioabsorbable

bioBLOCK® Subtalar Implant System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Subtalar implant, non-bioabsorbable.

HORIZON HYBRID SUBTALAR 12MM — BIOPRO, INC. · Class II
HORIZON SUBTALAR GEN 2 10MM — BIOPRO, INC. · Class II
Subtalar MBA Implant System — Smith & Nephew, Inc. · Class II
LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC · Class II
HyProCure II Sinus Tarsi Stent Size 06 — Gramedica · Class II
HORIZON TITANIUM SUBTALAR 12MM — BIOPRO, INC. · Class II
HORIZON TITANIUM SUBTALAR 6MM — BIOPRO, INC. · Class II
HORIZON SUBTALAR GEN 2 6MM — BIOPRO, INC. · Class II

Cleared under the same submission

K051611 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ascension Orthopedics, Inc.

Sources (1)

FDA UDI e2277bf3-342f-432b-99af-8951f16887be 39 fields · synced May 30, 2026