510(k) Report

Devices descending from K991026

7 later devices reach Reflection Crosslinked Uhmwpe Acetabular Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+1K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+2K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+2K243444Bioceram Azul® HeadKyocera Corporation20240—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—