Tibial Insert Trial, PS-Max, Klassic ONE

FDA UDI

Class I (US FDA UDI)

by Total Joint Orthopedics, Inc.

Identity

Trade Name: Tibial Insert Trial, PS-Max, Klassic ONE FDA UDI
Generic Name: Knee tibia prosthesis trial, reusable FDA UDI
Device Name: Tibial Insert Trial, PS-Max, Klassic ONE Size 1, 21mm FDA UDI
Model / Reference: 2252.01.021 FDA UDI
Description: Tibial Insert Trial, PS-Max, Klassic ONE Size 1, 21mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00819251028639 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Knee tibia prosthesis trial, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Knee tibia prosthesis trial, reusable

The Tibial Insert Trial, PS-Max, Klassic ONE is a reusable knee tibia prosthesis trial designed for unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. This graduated-size trial includes features such as tibial base plate trials, tibial spacer trials, tibial insert trials, and guide pin trials, all made of metal or polymer material.

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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 I	Pending data

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Manufacturer

Manufacturer: Total Joint Orthopedics, Inc.

Sources (1)

FDA UDI bc98507f-fb19-4a0c-bfa1-7376b90ce08b 36 fields · synced Jul 21, 2026