Panels › Orthopedic › Product code MBI · Class 2
Fastener, Fixation, Nondegradable, Soft Tissue
Regulation 888.3040
33510(k)s in 12 months (606 all time)
0recalls in 12 months (113 all time)
104recalls that name a 510(k)
Top companies in MBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Arthrex, Inc. | 52 | 1 |
| ArthroCare Corporation | 31 | 1 |
| Axya Medical, Inc. | 5 | 24 |
| Smith & Nephew | 23 | 5 |
| Riverpoint Medical | 23 | 1 |
| Parcus Medical | 23 | 0 |
| Innovasive Devices, Inc. | 22 | 0 |
| Biomet, Inc. | 10 | 10 |
| CONMED Corporation | 16 | 1 |
| Stryker | 10 | 6 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2025 | Biomet, Inc. BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair Open, Classified |
MBI | K130033 |
| Sep 23, 2025 | Biomet, Inc. Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 Open, Classified |
MBI | K110879 |
| Mar 12, 2025 | Stryker Corporation Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197 Open, Classified |
MBI | K151314 |
| Nov 29, 2024 | Smith & Nephew Inc. BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. Open, Classified |
MBI | K071586 K152566 |
| Dec 8, 2023 | Riverpoint Medical, LLC Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520
Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521
The Iconix Knotless anchors are intended to be use Open, Classified |
MBI | K231278 |
| Sep 28, 2023 | Stryker Corporation Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462 Open, Classified |
MBI | K131769 |
| Jul 3, 2023 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Part Number: 11 Open, Classified |
MBI | None listed |
| Jul 3, 2023 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Part Number:110 Open, Classified |
MBI | K210498 |
| Sep 22, 2022 | Paragon 28, Inc. Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System Open, Classified |
MBI | K211002 |
| Dec 17, 2020 | Biomet, Inc. Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation. Terminated |
MBI | K934469 |
| Jun 24, 2020 | Smith & Nephew, Inc. SUTUREFIX ULTRA Suture, Product number 72203855 Open, Classified |
MBI | K122059 |
| Jun 5, 2020 | OrthoPediatrics Corp OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction Terminated |
MBI | None listed |
| Jun 5, 2020 | OrthoPediatrics Corp OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction Terminated |
MBI | K130217 |
| Mar 17, 2020 | Smith & Nephew, Inc. Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm
Part Number: 72202902 Open, Classified |
MBI | K093897 |
| Mar 17, 2020 | Smith & Nephew, Inc. Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5
Part Number: 72202901 Open, Classified |
MBI | K093897 |
| Mar 2, 2020 | Stryker Corporation Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197 Terminated |
MBI | K181083 |
| Mar 2, 2020 | Stryker Corporation Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197 Terminated |
MBI | K181083 |
| Dec 30, 2019 | Smith & Nephew, Inc. TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone. Terminated |
MBI | K152566 K972326 |
| Nov 19, 2018 | Arthrex, Inc. Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT
Product Usage:
Soft tissue fixation to bone in Open, Classified |
MBI | K180118 |
| Aug 3, 2018 | Zimmer Biomet, Inc. Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and W Terminated |
MBI | K110145 |
| Jul 16, 2018 | Valeris Medical, LLC Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, S Terminated |
MBI | K133036 |
| Jan 22, 2018 | Valeris Medical, LLC Apollo XT Suture Anchor, 5.5 x 15
Product Usage:
Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicula Terminated |
MBI | K142230 |
| Oct 25, 2017 | Zimmer Biomet, Inc. fastener, fixation, nondegradable, soft tissue Terminated |
MBI | K143037 |
| Oct 11, 2017 | Zimmer Biomet, Inc. TunneLoc Tibial Fixation Device (Within an ACL Kit)
Product Usage:
To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate Terminated |
MBI | K103145 |
| Oct 11, 2017 | Zimmer Biomet, Inc. TunneLoc Tibial Fixation Device
Product Usage:
To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reco Terminated |
MBI | K103145 |
| Aug 22, 2017 | Zimmer Biomet, Inc. Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue. Terminated |
MBI | K083070 K130033 |
| Apr 17, 2017 | ConMed Corporation Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures. Terminated |
MBI | K091549 |
| Jul 7, 2016 | Synthes (USA) Products LLC Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue Terminated |
MBI | K994364 |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Fastener, fixation, nondegradable, soft tissue. Terminated |
MBI | K083070 K110145 +3 |
| Apr 12, 2016 | Stryker Corporation CinchLock Flex Knotless Anchor with Inserter;
Model number CAT02643;
Orthopedic:
The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradab Terminated |
MBI | K151314 |
| Apr 12, 2016 | Stryker Corporation CinchLock SS Knotless Anchor with Inserter;
Model number CAT02462;
Orthopedic:
The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradabl Terminated |
MBI | K131769 |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange - 5.5mm BioComposite Corkscrew FT,
Vented Suture Anchor;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number AR-1927BCF;
EXP (repackager), Arthrex (OEM)
Fastener Terminated |
MBI | None listed |
| Aug 29, 2014 | OrthoPediatrics Corp ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm
Product Usage:
The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL recon Terminated |
MBI | K130217 |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra S Double Loaded Suture
Product Code: 72203854
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | K122059 |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white)
Product Code: 72203853
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | K122059 |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue)
Product Code: 72203852
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | K122059 |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture
Product Code: 72203842
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | K122059 |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue
Product Code: 72203841
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | K122059 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
MBI | K052572 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
MBI | K052572 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
MBI | K052572 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
MBI | K052572 |
| Dec 26, 2013 | OrthoPediatrics Corp OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm Terminated |
MBI | K130217 |
| Nov 19, 2013 | Biomet, Inc. Juggerknotless Drill Bit, REF 110003173,
Sterile, Single Use
Product Usage:
The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wr Terminated |
MBI | K123485 |
| May 8, 2013 | Medshape Solutions, INC. ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230.
For use in the fixation of ligaments, tendons or soft tissue grafts to bone. Terminated |
MBI | K111471 |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical procedures Terminated |
MBI | K112965 |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical procedu Terminated |
MBI | K112965 |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical proc Terminated |
MBI | K112965 |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical proc Terminated |
MBI | K112965 |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical procedu Terminated |
MBI | K112965 |
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