World Knee PS All Poly Tibia

FDA UDI

Class II (US FDA UDI)

by Signature Orthopaedics Pty Ltd

Identity

Trade Name: World Knee PS All Poly Tibia FDA UDI
Generic Name: Uncoated knee tibia prosthesis, polyethylene FDA UDI
Model / Reference: 121-20-6508 FDA UDI

Identifiers

Primary DI / UDI-DI: 09348215116118 FDA UDI
510(k) Number: K181530 FDA UDI
FDA Product Code: JWH FDA UDI
MBH FDA UDI
GMDN Term: Uncoated knee tibia prosthesis, polyethylene FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3565 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

Category: Uncoated knee tibia prosthesis, polyethylene

World Knee PS All Poly Tibia by Signature Orthopaedics Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Signature Orthopaedics Pty Ltd

Sources (1)

FDA UDI 14936e0e-2c44-4574-a7ea-8f03e644af9d 33 fields · synced Jun 6, 2026