Invision

FDA UDI

Class II (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name: INVISION FDA UDI
Generic Name: Fixed-bearing total ankle prosthesis FDA UDI
Model / Reference: 6100503R FDA UDI

Identifiers

Catalog Number: 6100503R FDA UDI
Primary DI / UDI-DI: 00889797069090 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

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

MRI Safety

MR Conditional FDA UDI

Category: Fixed-bearing total ankle prosthesis

The INVISION is a fully FDA-approved, custom-made, fixed-bearing total ankle prosthesis designed to replace damaged and/or degenerative joint articulating surfaces. It includes tibial and talar components made of metal and polyethylene, with a PE bearing attached to one component. The implantation process may be performed without bone cement.

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 677a2ebf-d2a1-4c83-8e71-e4116a5ffb1b 35 fields · synced Jul 11, 2026