510(k) Report

Devices descending from K970501

509 later devices reach Pegged Acetabular Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+12K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+12K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+12K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+12K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+13K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+14K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+14K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+14K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—