TriVisc
by Channel-Markers Medical, LLC
PMA P160057
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP160057 | Date13 Nov 2017 | 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- Withdrawn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
TriVisc is an intraarticular acid, hyaluronic injection classified as a Class III medical device. It is designed to provide symptomatic relief for osteoarthritis of the knee in patients who have not adequately responded to conservative non-pharmacologic therapies and simple analgesics.
The device is administered via intraarticular injection into the knee joint and is supplied in sterile, single-use vials. It is regulated under an FDA Premarket Approval (PMA) with the approval number P160057, and its use is restricted to the specified orthopedic indication. Storage and handling must comply with sterile injection protocols.
Other devices from Channel-Markers Medical, LLC
Questions
AI-generated answers, 18 Sep 2026
What is the primary clinical use of TriVisc, and who is it intended for?
TriVisc is an intraarticular acid, hyaluronic injection specifically indicated for providing symptomatic relief of pain in patients with osteoarthritis of the knee who have not responded adequately to conservative non-pharmacologic therapies or simple analgesics like acetaminophen. It is not intended for general joint pain or other conditions.
How is TriVisc supplied, and is it reusable?
TriVisc is supplied in sterile, single-use vials, meaning each vial is designed for one-time administration only. This ensures sterility and safety for the patient, as reuse could compromise sterility and lead to infection risks.
What regulatory pathway does TriVisc follow, and how does this affect its use?
TriVisc follows the FDA Premarket Approval (PMA) pathway, with approval number P160057. This means its use is strictly regulated and limited to the specified indication—pain relief for osteoarthritis of the knee in patients who have failed conservative treatments. Clinicians must adhere to the approved labeling and protocols.
Are there multiple sizes or models of TriVisc available?
Yes, TriVisc is available in multiple sizes or models, as indicated by the registration numbers (e.g., 3002864272, 3007093114, etc.). These likely correspond to different vial sizes or formulations, though exact volumes or variations are not specified in the data. Always verify the correct model for your clinical application.
What storage and handling precautions should be taken with TriVisc?
TriVisc must be stored and handled according to sterile injection protocols to maintain its sterility. Since it is a single-use device, unopened vials should be stored in a clean, dry place away from direct sunlight or extreme temperatures until ready for use. Always follow manufacturer guidelines for preparation and administration.