Acera Surgical

Summary

Eight unique FDA 510(k) clearances were identified for the displayed current product families: three Cerafix decisions, four Restrata / Restrata STR decisions, and one MiniMatrix decision. Shared Restrata clearances are counted once across sheet and meshed forms. Wound-matrix records are unclassified under QSZ; STR and Cerafix have Class II records. ^{[13][15][17][19][21][23][25][27]}

FDA cleared Restrata K261245 on October 16, 2026. Solventum’s October 19 announcement reports clearance for combined use with specified V.A.C. Therapy components. The public decision record was verified; its downloadable clearance summary was unavailable during review, so the precise combined-use scope is attributed to Solventum. Refer to current device instructions for compatible components and restrictions. ^[27][6]

One Class II recall event was found: Z-1030-2022, initiated March 21, 2022 for a shelf-box expiration-date misprint affecting 83 units of Restrata RWM1-2X2, lot 51745. FDA lists the event as terminated on August 20, 2024. This is a historical lot-specific event, not evidence that the current portfolio is recalled. ^[28]

Named searches of published FDA PMA and De Novo databases found no matching original PMA approvals or De Novo grants for Acera, Restrata or Cerafix. ^{[30][31][32][33]}