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510(k) K150209 · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor

Applicant	Depuy Mitek, A Johnson and Johnson Company, Raynham MA, US
Decision	Substantially Equivalent, Oct 6, 2015
Received	Jan 30, 2015
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K150209

Date	Firm and product	Code	Linked 510(k)
Jun 2, 2023	DePuy 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	MAI	None listed
Jun 2, 2023	DePuy 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	MAI	None listed
Jun 2, 2023	DePuy 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	MAI	None listed
Jun 2, 2023	DePuy 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	MAI	None listed
Jun 2, 2023	DePuy 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	MAI	None listed

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