FDA Product Code
FDA Product Code MBI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3040
510(k) Clearances — 604 records · page 3 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K193092 | TunneLoc Tibial Fixation Device | Biomet, Inc. | 2020-01-02 | Traditional | PDF ↗ |
| K191426 | FiberTak Button | Arthrex, Inc. | 2019-11-26 | Special | PDF ↗ |
| K192964 | Parcus Synd-EZ SS | Parcus Medical, LLC | 2019-11-22 | Special | PDF ↗ |
| K191783 | Parcus Synd-EZ Ti | Parcus Medical, LLC | 2019-10-09 | Special | PDF ↗ |
| K192428 | AFX Femoral Implant with Inserter | Cayenne Medical | 2019-10-05 | Special | PDF ↗ |
| K190288 | Arthrex Tenodesis Button | Arthrex, Inc. | 2019-09-13 | Traditional | PDF ↗ |
| K191459 | JuggerStitch Meniscal Repair Device | Biomet, Inc. | 2019-09-13 | Traditional | PDF ↗ |
| K191300 | MectaLock Ti Suture Anchor | Medacta International S.A. | 2019-09-12 | Traditional | PDF ↗ |
| K191319 | Dunamis Fixation Button System | Dunamis, LLC | 2019-08-29 | Traditional | PDF ↗ |
| K190774 | RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant | Medos International SARL | 2019-07-25 | Traditional | PDF ↗ |
| K191053 | Xtreme-Loop | Xiros, Ltd. | 2019-07-17 | Traditional | PDF ↗ |
| K191204 | Infinity Fixation System | Conmed Corporation | 2019-07-03 | Special | PDF ↗ |
| K190915 | OsteoFab Suture Anchors | Oxford Performance Materials, Inc. | 2019-07-03 | Traditional | PDF ↗ |
| K191483 | HEALIX ADVANCE Anchor with DYNA+TAPE Sutures | Medos International SARL | 2019-06-28 | Special | PDF ↗ |
| K190892 | MectaScrew PEEK Interference Screw | Medacta International S.A. | 2019-06-04 | Traditional | PDF ↗ |
| K190474 | MectaLock PEEK Suture Anchor | Medacta International S.A. | 2019-05-28 | Traditional | PDF ↗ |
| K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | T.A.G. Medical Products Corporation, Ltd. | 2019-05-19 | Traditional | PDF ↗ |
| K190375 | Parcus ATLAS | Parcus Medical, LLC | 2019-04-24 | Special | PDF ↗ |
| K190728 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2019-04-17 | Special | PDF ↗ |
| K190446 | Responsive Arthroscopy Wedge Push-In Suture Anchors | Responsive Arthroscopy, LLC | 2019-03-27 | Special | PDF ↗ |
| K190333 | Paradigm All-Suture Anchor 1.8mm, White/Black #2 | Conmed Corporation | 2019-03-18 | Special | PDF ↗ |
| K183690 | Tenodesis Screw System | Paragon 28, Inc. | 2019-03-01 | Traditional | PDF ↗ |
| K182941 | HEALIX ADVANCE SP PEEK Anchor | Medos International SARL | 2019-02-26 | Traditional | PDF ↗ |
| K183279 | HEALIX Ti ANCHOR with DYNACORD | Medos International SARL | 2019-02-21 | Traditional | PDF ↗ |
| K183331 | Parcus GFS BTB | Parcus Medical, LLC | 2019-02-07 | Special | PDF ↗ |
| K182507 | Tigon Medical Tissue Anchors | Tigon Medical | 2019-01-21 | Traditional | PDF ↗ |
| K181076 | Responsive Arthroscopy Wedge Push-In Suture Anchors | Responsive Arthroscopy, LLC | 2019-01-18 | Traditional | PDF ↗ |
| K182898 | TenoTac Soft Tissue Fixation System | Paragon 28, Inc. | 2019-01-14 | Traditional | PDF ↗ |
| K181086 | Cortical Fixation Systems | Cousin Biotech Sas | 2019-01-09 | Traditional | PDF ↗ |
| K182439 | TruShot with Y-Knot Shallow All-Suture Anchor | Conmed Corporation | 2019-01-08 | Traditional | PDF ↗ |
| K182621 | CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver | Conmed Corporation | 2019-01-04 | Special | PDF ↗ |
| K180951 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | 2019-01-03 | Traditional | PDF ↗ |
| K182736 | OIC Suture Anchor System | The Orthopaedic Implant Company | 2018-12-28 | Traditional | PDF ↗ |
| K181120 | 2.8 mm/3.3 mm PopLok Suture Anchors | Conmed Corporation | 2018-12-21 | Special | PDF ↗ |
| K182446 | TruShot with Y-Knot All-Suture Anchor | Conmed Corporation | 2018-12-19 | Special | PDF ↗ |
| K182264 | ICONN Revolution Knotless Suture Anchor | Iconn Orthopedics, LLC | 2018-10-19 | Traditional | PDF ↗ |
| K181769 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2018-09-21 | Traditional | PDF ↗ |
| K181513 | Arthrex PushLock Tenodesis Anchor | Arthrex, Inc. | 2018-08-30 | Special | PDF ↗ |
| K180759 | SECULOK Suture Anchor | U&I Corporation | 2018-08-09 | Traditional | PDF ↗ |
| K181680 | ICONN Answer II Suture Anchor | Iconn Orthopedics, LLC | 2018-08-09 | Traditional | PDF ↗ |
| K173845 | Arthrex SwiveLock | Arthrex, Inc. | 2018-08-06 | Traditional | PDF ↗ |
| K181083 | Stryker All-PEEK Knotless Anchor System | Stryker | 2018-07-23 | Traditional | PDF ↗ |
| K180464 | AEVUMED PHANTOM Suture Anchors | Aevumed, Inc. | 2018-05-31 | Traditional | PDF ↗ |
| K173269 | KATOR Suture Anchor | Kator, LLC | 2018-05-30 | Traditional | PDF ↗ |
| K173074 | ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor | Stryker | 2018-04-04 | Special | PDF ↗ |
| K180274 | Ventix Link Knotless Anchor with Inserter | Cayenne Medical, Inc. | 2018-03-21 | Traditional | PDF ↗ |
| K180118 | Arthrex NanoSuture Anchor | Arthrex, Inc. | 2018-02-12 | Special | PDF ↗ |
| K173278 | ToggleLoc System | Biomet, Inc. | 2018-01-05 | Traditional | PDF ↗ |
| K172491 | ICONN Square 2.5MM Suture Anchor | Iconn Orthopedics, LLC | 2017-11-29 | Traditional | PDF ↗ |
| K172921 | Stryker Self-Punching ICONIX | Stryker | 2017-11-20 | Traditional | PDF ↗ |
| K171640 | M-ARS ACL: Anatomic Ribbon Surgery System | Medacta International S.A. | 2017-10-23 | Traditional | PDF ↗ |
| K172186 | BioWick X Implant with Driver | Cayenne Medical, Inc. | 2017-10-16 | Traditional | PDF ↗ |
| K172612 | FiberTak DX | Arthex, Inc. | 2017-09-28 | Special | PDF ↗ |
| K171964 | LigaMetrics Suture Anchors | Mortise Medical, LLC | 2017-09-19 | Traditional | PDF ↗ |
| K171725 | CuffLink Implant System | Conmed Corporation | 2017-09-08 | Traditional | PDF ↗ |
| K171465 | Stryker Self-Punching ICONIX | Stryker | 2017-08-24 | Traditional | PDF ↗ |
| K172165 | Q-Fix Suture Anchor | ArthroCare Corporation | 2017-08-17 | Special | PDF ↗ |
| K170388 | ANCHORMAN Tibial Ligament Fixation Device | Summit Medical , Ltd. | 2017-07-25 | Traditional | PDF ↗ |
| K170877 | Parcus SLiK Fix Screw | Parcus Medical | 2017-06-02 | Traditional | PDF ↗ |
| K171060 | OrthoButton AL | Riverpoint Medical | 2017-06-02 | Special | PDF ↗ |
| K171020 | Arthrex Knotless SutureTak Anchor | Arthrex, Inc. | 2017-05-16 | Traditional | PDF ↗ |
| K170098 | ICONIX TT All Suture Anchor | Stryker | 2017-03-31 | Special | PDF ↗ |
| K170327 | Parcus SLiK Anchors | Parcus Medical | 2017-03-30 | Traditional | PDF ↗ |
| K170265 | GRAVITYTM PEEK-OPTIMA Suture Anchor | Wrightmedicaltechnologyinc | 2017-02-23 | Special | PDF ↗ |
| K163258 | CrossFT Knotless Suture Anchor with Disposable Driver | Conmed Corporation | 2017-01-25 | Special | PDF ↗ |
| K163034 | SUTUREFIX Curved Suture Anchor | Smith and Nephew, Inc. | 2016-12-07 | Traditional | PDF ↗ |
| K162198 | GFS Ultimate | Parcus Medical, LLC | 2016-11-18 | Special | PDF ↗ |
| K162386 | KATOR Suture Anchor | Kator, LLC | 2016-10-25 | Special | PDF ↗ |
| K161033 | AFX Femoral Implant With Inserter | Cayenne Medical, Inc. | 2016-08-03 | Special | PDF ↗ |
| K160996 | Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm | Dunamis, LLC | 2016-07-06 | Traditional | PDF ↗ |
| K161001 | MILAGRO ADVANCE PEEK Interference Screw | Medos International SARL | 2016-06-09 | Traditional | PDF ↗ |
| K160655 | OrthoButton CL | Riverpoint Medical | 2016-06-03 | Traditional | PDF ↗ |
| K160319 | FiberTak DR | Arthrex, Inc. | 2016-05-10 | Special | PDF ↗ |
| K153585 | Flip Button Suture Anchor | First Ray, LLC | 2016-05-05 | Traditional | PDF ↗ |
| K160118 | STROPP (Single Tunnel Repair of Plantar Plate) | Crossroads Extremity Systems, LLC | 2016-05-03 | Traditional | PDF ↗ |
| K153558 | Ventix Suture Anchor | Biomet Manufacturing Corp | 2016-04-21 | Traditional | PDF ↗ |
| K160500 | Elite SPK, Compasso, Elite SPK Kit | Ncs Lab Srl | 2016-04-20 | Traditional | PDF ↗ |
| K153667 | TRUESPAN Meniscal Repair System | Medos International SARL | 2016-03-24 | Traditional | PDF ↗ |
| K152262 | Ventix Knotless Anchors | Biomet Manufacturing Corp | 2016-03-08 | Traditional | PDF ↗ |
| K151092 | Arthrex Short Suture Anchors | Arthrex, Inc. | 2016-02-23 | Traditional | PDF ↗ |
| K153186 | Adjustable Fixation Device | Arthrocare Corp. | 2016-01-28 | Traditional | PDF ↗ |
| K153669 | MultiFIX S Ultra Knotless Fixation System | Arthocare Corporation | 2016-01-19 | Special | PDF ↗ |
| K153313 | SpeedLock Knotless Fixation System | ArthroCare Corporation | 2015-12-11 | Special | PDF ↗ |
| K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors | Smith & Nephew, Inc. | 2015-12-02 | Traditional | PDF ↗ |
| K152711 | Parcus GFS Naked | Parcus Medical, LLC | 2015-11-20 | Special | PDF ↗ |
| K151004 | PULLUP® Adjustable Juxtacortical Fixation Device | Sbm Sciences For Bio Materials | 2015-11-17 | Traditional | PDF ↗ |
| K152255 | BoneCam Suture Anchors | Valeris Medical | 2015-11-16 | Traditional | PDF ↗ |
| K152236 | KATOR Suture Anchor | Kator, LLC | 2015-11-04 | Traditional | PDF ↗ |
| K151220 | Dunamis Interference Screw | Dunamis, LLC | 2015-10-14 | Traditional | PDF ↗ |
| K151601 | SECURE-LOOP | Xiros, Ltd. | 2015-09-09 | Traditional | PDF ↗ |
| K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015-09-04 | Traditional | PDF ↗ |
| K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm | Arthrex, Inc. | 2015-08-20 | Traditional | PDF ↗ |
| K151897 | MultiFIX® P Knotless Fixation Device | ArthroCare Corporation | 2015-08-06 | Special | PDF ↗ |
| K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors | Tornier, Inc. | 2015-07-28 | Traditional | PDF ↗ |
| K151068 | SureLock W Suture Anchor | Cayenne Medical, Inc. | 2015-07-24 | Traditional | PDF ↗ |
| K151314 | CinchLock Flex Knotless Suture Anchor | Pivot Medical | 2015-07-23 | Special | PDF ↗ |
| K151660 | MultiFIX S Knotless Fixation System | ArthroCare Corporation | 2015-07-16 | Special | PDF ↗ |
| K151037 | GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle | Conmed Corporation | 2015-07-09 | Special | PDF ↗ |
| K143745 | Arthrex Corkscrew and SwiveLock Suture Anchors | Arthrex, Inc. | 2015-07-02 | Traditional | PDF ↗ |
| K151201 | Stryker ICONIX with Needles | Stryker | 2015-06-29 | Traditional | PDF ↗ |
Product code MBI · Class II · Orthopedic. Data: openFDA.