Bioarch

FDA UDI

Class II (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name: BIOARCH FDA UDI
Generic Name: Subtalar implant, non-bioabsorbable FDA UDI
Model / Reference: ST1111 FDA UDI

Identifiers

Catalog Number: ST1111 FDA UDI
Primary DI / UDI-DI: 00840420128911 FDA UDI
FDA Product Code: HWC 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

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 11 Millimeter FDA UDI

Category: Subtalar implant, non-bioabsorbable

Bioarch by Wright Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Subtalar implant, non-bioabsorbable.

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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
bioBLOCK® Subtalar Implant System — Ascension Orthopedics, Inc. · Class II

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: Wright Medical Technology, Inc.

Sources (1)

FDA UDI 6b4dfd96-d5ee-40e5-b04b-4c48a7a768e6 35 fields · synced Jun 8, 2026