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: 200222902 FDA UDI

Identifiers

Catalog Number: 200222902 FDA UDI
Primary DI / UDI-DI: 00840420124081 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

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Contains Latex

FDA UDI

Prescription Use

Yes

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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

Category: Fixed-bearing total ankle prosthesis

Introducing the INBONE, a cutting-edge fixed-bearing total ankle prosthesis designed for individuals with damaged or degenerative joint conditions. This innovative device combines advanced materials and fixation systems to provide superior stability and comfort.

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 6cf9908c-0a1c-4514-a223-a51d369dbedf 35 fields · synced Jul 10, 2026