ClearanceBrief
510(k) K102380 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

EVOLUTION MP TOTAL KNEE SYSTEM

ApplicantWrightmedicaltechnologyinc, Arlington TN, US
DecisionSubstantially Equivalent, Jan 7, 2011
ReceivedAug 23, 2010
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K102380

DateFirm and productCodeLinked 510(k)
Dec 18, 2024MicroPort Orthopedics Inc.
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
Open, Classified
MBHNone listed
Jul 1, 2024MicroPort Orthopedics Inc.
EVOLUTION MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
Open, Classified
HRYNone listed
Nov 22, 2022MicroPort Orthopedics Inc.
EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
Terminated
HRYNone listed
Nov 22, 2022MicroPort Orthopedics Inc.
EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
Terminated
HRYNone listed

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