MOTO Partial Knee System Extension
Summary
Medacta International S.A. received 510(k) clearance for MOTO Partial Knee System Extension, a HSX device. Cleared on 2025-07-24.
Details
Source
510(k) Clearance
External ID
K251618
Action Date
2025-07-24
Status
Traditional
Category
device
Product Code
HSX
Product Description
MOTO Partial Knee System Extension. Product code: HSX.
Company
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. Medacta International S.A. has received 58 total clearances in our database.
Medacta International S.A. has 58 FDA actions in our database, including 58 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 Medacta International S.A. have FDA actions?
Medacta International S.A. has 58 FDA actions in our database, including 0 recalls and 58 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251618" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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