510(k) Report

Devices descending from K112786

5 later devices reach Proseries Bioimplants-Proankle/Procuff through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+2K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+2K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+2K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+3K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—