ClearanceBrief
Panels › Orthopedic › Product code MAI · Class 2

Fastener, Fixation, Biodegradable, Soft Tissue

Regulation 888.3030

5510(k)s in 12 months (221 all time)
9recalls in 12 months (97 all time)
96recalls that name a 510(k)
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Top companies in MAI

Company510(k)sRecalls
Arthrex, Inc.467
Smith & Nephew, Inc.1043
Depuy Mitek, A Johnson & Johnson Company1825
Aju Pharm Co., Ltd.58
Smith & Nephew Inc., Endoscopy Division112
Bionx Implants, Inc.110
Linvatec Corp.110
Medos International SARL80
Conmed Corporation51
Acuitive Technologies50
DateFirm and productCodeLinked 510(k)
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
Open, Classified		 MAIK151105
Nov 4, 2019DePuy Mitek, Inc., a Johnson & Johnson Co.
Healix Knotless ADV BR 5.5 Suture Anchor
Terminated		 MAIK130917
Nov 4, 2019DePuy Mitek, Inc., a Johnson & Johnson Co.
Healix Knotless ADV BR 4.75 Suture Anchor
Terminated		 MAIK130917
Dec 11, 2017Smith & Nephew, Inc.
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Terminated		 MAIK952535
Mar 24, 2017Arthrex, Inc.
Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Terminated		 MAIK101823
Mar 24, 2017Arthrex, Inc.
Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Terminated		 MAIK101823
Mar 24, 2017Arthrex, Inc.
Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Terminated		 MAIK101823
Mar 24, 2017Arthrex, Inc.
Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Terminated		 MAIK101823
Mar 24, 2017Arthrex, Inc.
Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Terminated		 MAIK101823
Mar 24, 2017Arthrex, Inc.
Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Terminated		 MAIK101823
Jul 19, 2016Smith & Nephew, Inc.
Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
Terminated		 MAIK952535
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor
Terminated		 MAIK093844
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor
Terminated		 MAIK093844
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612 Biodegradable suture anchor
Terminated		 MAIK093844
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor
Terminated		 MAIK093844
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor
Terminated		 MAIK093844
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor
Terminated		 MAIK093844
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor
Terminated		 MAINone listed
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor
Terminated		 MAIK093844
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor
Terminated		 MAIK093844
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
Terminated		 MAIK093844
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 Biodegradable suture anchor
Terminated		 MAIK093844
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 Biodegradable suture anchor
Terminated		 MAIK093844
Jul 1, 2013Linvatec Corp. dba ConMed Linvatec
GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical
Terminated		 MAIK101100
Mar 6, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Terminated		 MAIK040827
Mar 6, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Terminated		 MAIK040827
Mar 6, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Mitek LUPINE BR DS W/ORTHCRD Catalog Number: 210712 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Terminated		 MAIK040827
Mar 6, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Mitek LUPINE BR W/ORTHCORD Catalog Number: 210711 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Terminated		 MAIK040827
Mar 6, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Mitek Lupine Loop Plus Anchor w/Ethibond Catalog Number: 210710 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Terminated		 MAIK040827
Mar 6, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Mitek LupineLoopPlus Anchor w/Orthocord DS Catalog Number: 210709 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Terminated		 MAIK040827
Mar 6, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Mitek Lupine Loop Plus Anchor w/Orthocord Catalog Number: 210708 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Terminated		 MAIK040827
Mar 6, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl Catalog Number: 210707 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Terminated		 MAIK040827
Mar 6, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Mitek- Lupine (Panalok) Loop Arthro #2 Panacryl Catalog Number: 210705 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Terminated		 MAIK040827
Mar 6, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond Catalog Number: 210704 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Terminated		 MAIK040827
Nov 30, 2011DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek Panalock Loop w/ Orthocord Catalog #222980 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.
Terminated		 MAIK040827
K070925
Nov 30, 2011DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek Lupine Loop Rapide w/ Orthocord Catalog #210711 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilizati
Terminated		 MAIK070925
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		 MAIK062170
K070925
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		 MAIK062170
K070925
Nov 30, 2011DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek Panalock Loop, Lupine Anchor Catalog #210704 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.
Terminated		 MAIK040827
K070925
Mar 15, 2006Depuy Mitek, a Johnson & Johnson Co.
Depuy Mitek Bioknotless Anchor with Panacryl Suture Ref No. 212729
Terminated		 MAIK002639
Mar 15, 2006Depuy Mitek, a Johnson & Johnson Co.
Depuy Mitek Bioknotless Anchor with Ethibond Suture Ref No. 212728
Terminated		 MAIK002639
Jan 26, 2006Depuy Mitek, a Johnson & Johnson Co.
Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740
Terminated		 MAIK041075

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