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)
Aug 26, 2026ConMed Corporation
CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile
Open, Classified		 MAIK101100
Jan 26, 2026Aju Pharm Co., Ltd.
AlternatiV+ Screw-In Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
AlternatiV+ Max Knotless Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
Genesis Push-In Suture Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
Genesis Knotless Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
Genesis Dual Thread Screw-In Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
Genesis Screw-In Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
Fixone Biocomposite Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
Fixone Hybrid Anchor
Open, Classified		 MAIK193497
K203523 +3
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		 MAIK040827
K062170 +2
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		 MAIK040827
K062170 +2
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		 MAIK040827
K062170 +2
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		 MAIK040827
K062170 +2
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		 MAIK040827
K062170 +2
Jun 14, 2021Arthrex, Inc.
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Open, Classified		 MAIK203495
Apr 8, 2021Smith & Nephew, Inc.
CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014
Terminated		 MAIK921481
Sep 9, 2020Smith & Nephew, Inc.
MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
Open, Classified		 MAIK151105
Sep 9, 2020Smith & Nephew, Inc.
TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
Open, Classified		 MAIK151105

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