Viscosupplement Bibliography

FDA PMAs/SSEDs, Package Inserts, Prescriber Instructions, and Patient Information

Single-Injection Products

Hymovis® ONE (Fidia) — single injection

PMA / SSED: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P150010S005
Instructions for Prescribers (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150010S005D.pdf
Patient Information (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150010S005C.pdf

Gel-One® (Zimmer Biomet) — single injection

PMA / SSED: https://www.accessdata.fda.gov/cdrh_docs/pdf8/P080020B.pdf
Package Insert (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf8/P080020S020D.pdf
Patient Information (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf8/P080020S020C.pdf

DUROLANE® (Bioventus) — single injection

PMA / SSED: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170007B.pdf
Instructions for Prescribers (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170007D.pdf
Patient Information (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170007C.pdf

MONOVISC® (Anika) — single injection

PMA / SSED: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090031
Information for Prescribers (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf9/P090031c.pdf
Patient Information (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf9/P090031d.pdf

Synvisc-One® (Sanofi) — hylan G-F 20, single injection

PMA Supplement / SSED: https://www.accessdata.fda.gov/cdrh_docs/pdf/P940015S012B.pdf
Prescribing Information (Sanofi): https://products.sanofi.us/synviscone/synviscone.pdf
Patient Labeling (Sanofi): https://products.sanofi.us/synviscone/synviscone.html

Multi-Injection Products

Hymovis® (Fidia) — 2-injection

PMA / SSED: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150010b.pdf
Prescribing Information (Fidia): https://hymovis.com/wp-content/uploads/2017/04/HYMOVIS_PI.pdf

EUFLEXXA® (Ferring) — 3-injection

PMA / SSED: https://www.accessdata.fda.gov/cdrh_docs/pdf/P040013B.pdf
Package Insert / Labeling (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf/P040013c.pdf
Patient Brochure (manufacturer): https://hcp.euflexxa.com/wp-content/uploads/2024/01/EUFLEXXA-Patient-Brochure-v2.0_US-EU-2300036-1.pdf

Synvisc® (Sanofi) — 3-injection hylan G-F 20

PMA / Approval (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf/P940015B.pdf
Prescribing Information (Sanofi): https://products.sanofi.us/synvisc/synvisc.pdf

SUPARTZ FX® (Bioventus/Seikagaku) — 5-injection

PMA / SSED: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160057B.pdf
PMA Page (latest labeling): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160057

VISCO-3™ (Seikagaku; US distribution via Bioventus) — 3-injection

PMA Supplement Page: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980044S027
Package Insert (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf/P980044S027D.pdf
Patient Information (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf/P980044S027C.pdf

TRILURON™ (Fidia Farmaceutici S.p.A.) — 3-injection

PMA / SSED: https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180040B.pdf
FDA PMA Page (labeling): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180040
Patient Information (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180040C.pdf

TriVisc® (OrthogenRx) — 3-injection

PMA Page (labeling): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160057
Patient Information (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160057C.pdf
Instructions / Prescribers (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160057D.pdf

GenVisc® 850 (OrthogenRx) — 5-injection

PMA Page (SSED + labeling): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140005
Package Insert (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140005D.pdf

HYALGAN® (Fidia) — 5-injection

PMA Page (SSED + labeling): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950027
Package Insert (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf/P950027a.pdf
Patient Info (manufacturer): https://www.hyalgan.com/patients/

GELSYN-3® (IBSA/Bioventus) — 3-injection

PMA / SSED (P110005): https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110005b.pdf
Instructions for Use / Prescribers (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110005d.pdf
Patient Information (FDA): https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110005c.pdf

Notes: If a classic FDA package insert is not posted (e.g., Hymovis ONE), the FDA’s Prescriber and Patient PDFs serve as current labeling. VISCO-3 is manufactured by Seikagaku (distributed by Bioventus in the US). Triluron is manufactured by Fidia Farmaceutici S.p.A. GELSYN-3 is PMA P110005 (IBSA/Bioventus).