Inbone

FDA UDI

Class II (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name: INBONE FDA UDI
Generic Name: Fixed-bearing total ankle prosthesis FDA UDI
Model / Reference: 200221954E FDA UDI

Identifiers

Catalog Number: 200221954E FDA UDI
Primary DI / UDI-DI: 00840420124661 FDA UDI
FDA Product Code: HSN FDA UDI
GMDN Term: Fixed-bearing total ankle prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3110 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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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

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Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

Yes

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MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Height — 13 Millimeter FDA UDI

Category: Fixed-bearing total ankle prosthesis

The INBONE is a cutting-edge, fixed-bearing total ankle prosthesis designed to replace damaged or degenerative joints. This implantable artificial substitute for an ankle joint offers unparalleled durability and performance, providing users with a safe and reliable solution.

Similar devices

Also classified as Fixed-bearing total ankle prosthesis.

APEX 3D S Total Ankle Replacement System — Paragon 28 · Class II
QUANTUM — IN2BONES · Class II
Salto Talaris® — Ascension Orthopedics, Inc. · Class II
APEX 3D Total Ankle Replacement System — Paragon 28 · Class II
XT Revision Ankle Replacement System — Smith & Nephew, Inc. · Class II
Salto Talaris Total Ankle Prosthesis — Smith & Nephew, Inc. · Class II
APEX 3D Total Ankle Replacement System — Paragon 28 · Class II
Vantage — Exactech, 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 876dd0cb-98d9-4e4b-85a3-531dc6017db0 35 fields · synced Jul 8, 2026