Anika Therapeutics, Inc.

• MQV — Orthopedic5 devices
• OWX — General, Plastic Surgery2 devices
• GDW — General, Plastic Surgery1 device
• MBI — Orthopedic1 device
• QSZ — Unknown1 device

• Z-2423-2018 — Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFFl 1 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth. Hyalomatrix is indicated for the management of wounds including: partial and full-thickness wounds; second-degree bums; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.Class II·Terminated·2018-05-10

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K261311 — HYALOMATRIXCode QSZ·2026-09-02
• K250997 — Integrity ImplantCode OWX·2025-06-17
• K231968 — Tactoset® Injectable Bone SubstituteCode MQV·2023-12-20
• K223538 — Integrity ImplantCode OWX·2023-08-17
• K223860 — Integrity Bone Staple Fixation SystemCode MBI·2023-05-22
• K222487 — Anika Tissue Tack Fixation SystemCode GDW·2023-05-08
• K223915 — TactosetCode MQV·2023-03-29
• K212083 — Tactoset Injectable Bone SubstituteCode MQV·2021-08-31
• K190956 — SCS 17-01Code MQV·2020-01-30
• K173008 — SCS 17-01Code MQV·2017-12-26