Synojoynt
by Mesoblast
PMA P170016
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP170016 | Date8 May 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Acid, hyaluronic, intraarticular
- PMA Number
- FDA Product Code
- MOZ
- Device Class
- Class III
- Advisory Committee
- Orthopedic
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
Synojoint Acid, Hyaluronic, Intraarticular is a Class III medical device classified as an intraarticular acid, hyaluronic preparation. It is designed to provide intraarticular administration of hyaluronic acid for therapeutic purposes in joint conditions, specifically targeting pain associated with osteoarthritis of the knee in patients unresponsive to conservative treatments and simple analgesics.
This device is administered via intraarticular injection into the knee joint under sterile conditions. It is supplied as a single-use product and is regulated under an FDA Premarket Approval (PMA) with PMA number P170016. The product is intended for use in clinical settings by healthcare professionals and is not reusable. No specific MRI safety information is provided in the available data.