World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)
Summary
Signature Orthopaedics Pty, Ltd. received 510(k) clearance for World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC), a JWH device. Cleared on 2022-04-11.
Details
Source
510(k) Clearance
External ID
K220737
Action Date
2022-04-11
Status
Special
Category
device
Product Code
JWH
Product Description
World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC). Product code: JWH.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Signature Orthopaedics Pty, Ltd. has received 20 total clearances in our database.
Signature Orthopaedics Pty, Ltd. has 20 FDA actions in our database, including 20 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Signature Orthopaedics Pty, Ltd. have FDA actions?
Signature Orthopaedics Pty, Ltd. has 20 FDA actions in our database, including 0 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K220737" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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