ClearanceBrief
510(k) K062170 ยท JDR Staple, Fixation, Bone

BIOKNOTLESS AND LUPINE PLUS ANCHORS

ApplicantDepuy Mitek, A Johnson & Johnson Company, Raynham MA, US
DecisionSubstantially Equivalent, Aug 22, 2006
ReceivedJul 31, 2006
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K062170

DateFirm and productCodeLinked 510(k)
Jun 2, 2023DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
Open, Classified		 MAINone listed
Jun 2, 2023DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
Open, Classified		 MAINone listed
Jun 2, 2023DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
Open, Classified		 MAINone listed
Jun 2, 2023DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
Open, Classified		 MAINone listed
Jun 2, 2023DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
Open, Classified		 MAINone listed
Nov 30, 2011DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek Lupine Loop Plus w/ Orthocord Catalog #210708 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilizat
Terminated		 MAINone listed
Nov 30, 2011DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobiliz
Terminated		 MAINone listed

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