ClearanceBrief
510(k) K884398 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS

ApplicantOsteonics Corp., Allendale NJ, US
DecisionSubstantially Equivalent for Some Indications, Jan 17, 1989
ReceivedOct 19, 1988
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K884398

DateFirm and productCodeLinked 510(k)
Jan 31, 2024Howmedica Osteonics Corp.
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
Open, Classified		 JWHNone listed
Jan 31, 2024Howmedica Osteonics Corp.
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
Open, Classified		 JWHNone listed

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