FDA Product Code
FDA Product Code HTN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3030
510(k) Clearances — 93 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253115 | LARS ACJ | Movmedix S.A.S. | 2026-06-10 | Traditional | PDF ↗ |
| K252081 | SportLinc Syndesmosis Device | Lincotek Medical | 2026-03-27 | Traditional | PDF ↗ |
| K253727 | Syndesmosis TightRope PRO | Arthrex, Inc. | 2025-12-22 | Special | PDF ↗ |
| K251643 | Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) | 2025-10-29 | Traditional | PDF ↗ |
| K251134 | RipCord | TriMed, Inc. | 2025-07-11 | Traditional | PDF ↗ |
| K243624 | Acu-Sinch Knotless Mini | Acumed, LLC | 2025-01-23 | Traditional | PDF ↗ |
| K242091 | Bolo Button System | Fusion Orthopedics | 2024-12-23 | Traditional | PDF ↗ |
| K243408 | TACTIX Vector Syndesmosis System | Vilex, LLC | 2024-11-27 | Special | PDF ↗ |
| K242311 | EXPERT - Flexible Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2024-11-01 | Traditional | PDF ↗ |
| K240035 | TACTIX Vector Syndesmosis System | Vilex, LLC | 2024-08-01 | Traditional | PDF ↗ |
| K240947 | TENSOR® Suture Button System | Globus Medical, Inc. | 2024-06-03 | Traditional | PDF ↗ |
| K233531 | OIC FLEX-FIX System | Orthopaedic Implant Company | 2024-02-02 | Traditional | PDF ↗ |
| K232780 | CC-Clip® Implant System | Cc-Instruments, Inc. | 2023-12-18 | Traditional | PDF ↗ |
| K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2023-10-06 | Special | PDF ↗ |
| K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2022-08-22 | Traditional | PDF ↗ |
| K220947 | Arthrex Knotless AC Repair Devices | Arthrex, Inc. | 2022-06-06 | Traditional | PDF ↗ |
| K220650 | TriMed Ripcord Device | TriMed, Inc. | 2022-06-01 | Traditional | PDF ↗ |
| K220260 | Hercules Syndesmosis Implant System | In2bones USA, LLC | 2022-03-31 | Traditional | PDF ↗ |
| K212990 | Acumed Ankle Syndesmosis Repair System | Acumed, LLC | 2022-01-07 | Traditional | PDF ↗ |
| K213644 | Arthrex Knotless Mini TightRopes | Arthrex, Inc. | 2021-12-17 | Special | PDF ↗ |
| K211612 | Medline UNITE REFLEX Dynamic Discs | Medline Industries, Inc. | 2021-12-10 | Traditional | PDF ↗ |
| K200332 | EXPERT - Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2020-10-29 | Traditional | PDF ↗ |
| K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | Arthrex, Inc. | 2020-09-03 | Traditional | PDF ↗ |
| K200361 | Akros Scruture Anchor LisFranc Repair Kit | Akros Medical | 2020-04-06 | Traditional | PDF ↗ |
| K190143 | LARS AC Band Device | Corin USA | 2019-11-04 | Traditional | PDF ↗ |
| K190582 | MicroLink All-Suture Button Fixation System (Radiopaque) | Conmed Corporation | 2019-06-28 | Traditional | PDF ↗ |
| K190516 | MicroLink All-Suture Button Fixation System (Radiolucent) | Conmed Corporation | 2019-06-28 | Traditional | PDF ↗ |
| K183094 | CyclaPlex Correction System | Cycla Orthopedics, Ltd. | 2019-04-26 | Traditional | PDF ↗ |
| K183232 | Double ENDOBUTTON Fixation Device | Smith and Nephew, Inc. | 2019-03-12 | Traditional | PDF ↗ |
| K180243 | Infinity-Lock Button System | Xiros, Ltd. | 2018-04-03 | Traditional | PDF ↗ |
| K171703 | PUMA System | Panther Orthopedics, Inc. | 2018-03-01 | Traditional | PDF ↗ |
| K173550 | Akros FibuLink Syndesmosis Repair Kit | Akros Medical | 2017-12-14 | Special | PDF ↗ |
| K172620 | SyndesMetrics Syndesmosis Repair System | Mortise Medical, LLC | 2017-11-08 | Traditional | PDF ↗ |
| K170249 | GRAVITY Syndesmosis LP | Wrightmedicaltechnologyinc | 2017-06-30 | Traditional | PDF ↗ |
| K162996 | INVISIKNOT Ankle Syndesmosis Repair Kit | Smith & Nephew, Inc. | 2017-06-08 | Traditional | PDF ↗ |
| K170440 | KISSloc Suture System | Arthrosurface, Inc. | 2017-05-03 | Traditional | PDF ↗ |
| K162805 | Akros Fibulink Syndesmosis Repair Kit | Akros Medical | 2017-01-10 | Traditional | PDF ↗ |
| K153211 | M-Fix Acromioclavicular Device | Coracoid Solutions, Inc. | 2016-02-02 | Traditional | PDF ↗ |
| K150359 | Tensyn Plug | Dallen Medical, Inc. | 2015-05-07 | Traditional | PDF ↗ |
| K143092 | Tensyn Plug | Dallen Medical, Inc. | 2015-02-11 | Traditional | PDF ↗ |
| K141420 | FASTFORWARD | MedShape, Inc. | 2014-12-18 | Traditional | PDF ↗ |
| K141264 | TENSYN BAND, TENSYN FRACTURE PLATES | Dallen Medical, Inc. | 2014-08-21 | Traditional | PDF ↗ |
| K141219 | JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS | Biomet Manufacturing Corp | 2014-07-18 | Traditional | PDF ↗ |
| K133835 | ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM | Arthrosurface, Inc. | 2014-07-03 | Traditional | PDF ↗ |
| K140328 | CMC MINI TIGHTROPE | Arthrex, Inc. | 2014-03-10 | Special | PDF ↗ |
| K133858 | TENSYN BAND | Dallen Medical, Inc. | 2014-02-28 | Traditional | PDF ↗ |
| K133275 | MINI TIGHTROPE | Arthrex, Inc. | 2014-01-30 | Traditional | PDF ↗ |
| K132733 | ORTHOHELIX SYNDESMOSIS FIXATION DEVICES | Orthohelix Surgical Designs, Inc. | 2014-01-03 | Traditional | PDF ↗ |
| K131850 | TENSYN BAND | Dallen Medical, Inc. | 2013-11-15 | Traditional | PDF ↗ |
| K132510 | BIOPRO - INFINITY PLATE ANCHOR SYSTEM | Biopro, Inc. | 2013-10-24 | Traditional | PDF ↗ |
| K130986 | FRAG-LOC SYSTEM | Acumed, LLC | 2013-07-23 | Traditional | PDF ↗ |
| K112437 | ARTHREX FRACTURE SYSTEM | Arthrex, Inc. | 2011-12-21 | Traditional | PDF ↗ |
| K112111 | ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR | Acumed, LLC | 2011-11-14 | Traditional | PDF ↗ |
| K111032 | CMC CABLE FIX | Instratek, Inc. | 2011-08-31 | Traditional | PDF ↗ |
| K091207 | SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE | Surgicraft , Ltd. | 2011-02-15 | Traditional | PDF ↗ |
| K091799 | CABLE READY CABLE GRIP SYSTEM CABLE BUTTON | Zimmer, Inc. | 2009-09-11 | Traditional | PDF ↗ |
| K091763 | MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 | Instratek, Inc. | 2009-08-14 | Special | PDF ↗ |
| K090107 | MINI TIGHTROPE | Arthrex, Inc. | 2009-08-06 | Traditional | PDF ↗ |
| K082384 | HAV-LOK BUNION CORRECTION SYSTEM | Instratek, Inc. | 2008-12-08 | Traditional | PDF ↗ |
| K082095 | ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE | Smith & Nephew Endoscopy, Inc. | 2008-10-21 | Traditional | PDF ↗ |
| K071978 | MINI TIGHTROPE FT REPAIR KIT | Arthrex, Inc. | 2007-08-15 | Special | PDF ↗ |
| K061925 | MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS | Arthrex, Inc. | 2006-10-31 | Traditional | PDF ↗ |
| K052776 | TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD | Arthrex, Inc. | 2005-12-13 | Traditional | PDF ↗ |
| K043145 | BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B | Arthrex, Inc. | 2005-02-18 | Traditional | PDF ↗ |
| K043411 | RESOFIX BIOABSORBABLE EXPANSION BOLT | Resofix, Inc. | 2005-02-17 | Traditional | PDF ↗ |
| K043248 | TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS | Arthrex, Inc. | 2005-02-16 | Traditional | PDF ↗ |
| K040250 | BONE-LOK HP WASHER | Triage Medical, Inc. | 2004-03-23 | Traditional | PDF ↗ |
| K030619 | ODI 7.0MM CANNULATED SCREW SYSTEM | Orthopedic Designs, Inc. | 2003-04-01 | Traditional | PDF ↗ |
| K023119 | BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B | Arthrex, Inc. | 2002-12-18 | Traditional | PDF ↗ |
| K013806 | SYNTHES METALLIC SPIKED WASHERS | Synthes (Usa) | 2002-02-08 | Traditional | PDF ↗ |
| K011583 | SPIKED WASHER | Synthes (Usa) | 2002-01-30 | Traditional | PDF ↗ |
| K003496 | CANNULATED SCREW SYSTEM | Pioneer Surgical Technology | 2001-02-08 | Traditional | PDF ↗ |
| K992617 | HEX BUTTON | Pioneer Surgical Technology | 1999-10-27 | Traditional | PDF ↗ |
| K991135 | SOFT TISSUE SUTURE WASHER | Depuy, Inc. | 1999-04-29 | Traditional | PDF ↗ |
| K983906 | DEPUY ORTHOTECH SPIKED WASHER | DePuy Orthopaedics, Inc. | 1998-12-18 | Traditional | PDF ↗ |
| K982354 | SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M | Special Devices, Inc. | 1998-11-23 | Traditional | PDF ↗ |
| K983265 | DEPUY ACE COMPOSITE LOCKING NUT | Depuy Ace Medical Co. | 1998-10-26 | Traditional | PDF ↗ |
| K980944 | SYNTHES SCHUHLI IMPLANT SYSTEM | Synthes (Usa) | 1998-04-27 | Traditional | PDF ↗ |
| K965028 | ACUMED SUTURE WASHER | Acu Med, Inc. | 1997-03-17 | Traditional | PDF ↗ |
| K963420 | CANCELLOUS SCREW WASHER | Orthopaedic Biosystems, Ltd. | 1996-11-15 | Traditional | PDF ↗ |
| K954682 | WASHER, BOLT, NUT, ORTHOPEDIC | Linvatec Corp. | 1996-02-09 | Traditional | PDF ↗ |
| K954148 | SUTURE WASHER | Acu Med, Inc. | 1996-01-17 | Traditional | PDF ↗ |
| K943782 | BONE SCREW WASHER | Acu Med, Inc. | 1994-12-20 | Traditional | PDF ↗ |
| K924455 | SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER | Synthes (Usa) | 1993-05-12 | Traditional | PDF ↗ |
| K914472 | SPIKED WASHER | Synthes (Usa) | 1991-11-07 | Traditional | PDF ↗ |
| K911306 | T-BOLT AND NUT | Danek Medical, Inc. | 1991-09-10 | Traditional | PDF ↗ |
| K910186 | WYMAN SUTURE WASHER | Acu Med, Inc. | 1991-07-25 | Traditional | PDF ↗ |
| K910229 | SOFT TISSUE SUTURE WASHER/3 HOLE WASHER | Depuy, Inc. | 1991-07-24 | Traditional | PDF ↗ |
| K895107 | ACE ORTHOPAEDIC WASHERS | Buckman Co., Inc. | 1989-09-11 | Traditional | PDF ↗ |
| K881699 | ACROMED WASHERS | Buckman Co., Inc. | 1988-04-27 | Traditional | PDF ↗ |
| K874669 | ACE BONE SCREW NUT | Buckman Co., Inc. | 1987-12-11 | Traditional | PDF ↗ |
| K843368 | KAPP SPINAL BUTTON | Kapp Surgical Instrument, Inc. | 1984-09-12 | Traditional | PDF ↗ |
| K834411 | TECHMEDICA-HEWSON SHOULDER CLEAT | Techmedica, Inc. | 1984-01-17 | Traditional | PDF ↗ |
Product code HTN · Class II · Orthopedic. Data: openFDA.