510(k) Report

Devices descending from K980774

11 later devices reach Osteonics Gap-II Restoration Acetabular Shells through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+1K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+1K032348Converge Reti-Lock Multi-Hole Reinforcement CupCenterpulse Orthopedics, Inc.20030—
+2K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—