World Knee System 121-20-0612

by Signature Orthopaedics Pty Ltd

World Knee System 121-20-0612 is a Class II device made by Signature Orthopaedics Pty Ltd, cleared under FDA 510(k) K180750 on 20 Apr 2018 and listed in FDA GUDID since 29 Nov 2018 (UDI-DI 09348215035501), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number09348215035501 UDI-DI	Date29 Nov 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK180750	Date20 Apr 2018Decided	StatusActive

Official records

AccessGUDID record UDI-DI 09348215035501
FDA 510(k) database 510(k) number K180750

Across registries

2 registries list this device

FDA 510(k) K180750 decided 20 Apr 2018 Active
FDA GUDID UDI-DI 09348215035501 listed 29 Nov 2018 Listed

Timeline

2 dated events

20 Apr 2018 Cleared FDA 510(k) K180750
29 Nov 2018 Listed FDA GUDID 09348215035501

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: World Knee System
Generic name: Uncoated knee femur prosthesis, metallic
Model / reference: 121-20-0612

Primary DI / UDI-DI: 09348215035501
510(k) Number: K180750
FDA product code: JWH
GMDN term: Uncoated knee femur prosthesis, metallic

Device class: Class II
Regulation number: 888.3560
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (8, all answered No)