ClearanceBrief
510(k) K233476 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Z1 Hip System

ApplicantOrchard Medical Development, Rosemont IL, US
DecisionSubstantially Equivalent, Feb 8, 2024
ReceivedOct 25, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K233476

DateFirm and productCodeLinked 510(k)
Mar 24, 2025Zimmer, Inc.
Z1 Femoral Hip System, Product Number 611777612
Open, Classified
LZONone listed

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