510(k) Report

Devices descending from K964472

9 later devices reach Riopro Cobalt Trapeziometarcarpal Resurfacing Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041451Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40…Ascension Orthopedics, Inc.200482
+2K112278Ascension Nugrip CMC ImplantAscension Orthopedic20110—
+2K061451Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc.200651
+2K042690Ascension Pyrosphere (PCS)Ascension Orthopedics, Inc.20043—
+3K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC20200—
+3K111068Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC20111—
+3K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC20091—
+3K080997Ascension Pyrocarbon LunateAscension Orthopedics, Inc.20082—
+3K060560Ascension Pyrosphere CMC/TMTAscension Orthopedics, Inc.200601