510(k) Report

Devices descending from K991227

3 later devices reach 8MM Forged Cemented Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121024Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8; Foundation Porous…Encore Medical L.P.20120—
+1K031165Plus Orthopedics Cemented Hip StemPlus Orthopedics20031—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302