ClearanceBrief
510(k) K121308 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

HIP SYSTEMS

ApplicantHowmedica Osteonics Corp., Mahwah NJ, US
DecisionSubstantially Equivalent, Jul 30, 2012
ReceivedMay 1, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K121308

DateFirm and productCodeLinked 510(k)
Dec 30, 2021Howmedica Osteonics Corp.
Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044
Terminated		 JDGNone listed
Dec 30, 2021Howmedica Osteonics Corp.
Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
Terminated		 JDGNone listed
Dec 21, 2021Howmedica Osteonics Corp.
32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
Open, Classified		 LPHNone listed
Oct 3, 2019Howmedica Osteonics Corp.
Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
Terminated		 LPHNone listed
Jul 21, 2017Howmedica Osteonics Corp.
Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
Terminated		 LPHNone listed
Jul 21, 2017Howmedica Osteonics Corp.
Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
Terminated		 LPHNone listed
Nov 10, 2015Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
Terminated		 LPHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.