510(k) Report

Devices descending from K041451

8 later devices reach Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30… through their predicates, nearest generation first.

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