HTN · Washer, Bolt Nut
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | HTN |
|---|---|
| Device Name | Washer, Bolt Nut |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Classification Rationale
Class II.
Cleared Devices (92)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252081 | SportLinc Syndesmosis Device | Lincotek Medical | Mar 27, 2026 | SESE |
| K253727 | Syndesmosis TightRope PRO | Arthrex, Inc. | Dec 22, 2025 | SESE |
| K251643 | Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) | Oct 29, 2025 | SESE |
| K251134 | RipCord | TriMed, Inc. | Jul 11, 2025 | SESE |
| K243624 | Acu-Sinch Knotless Mini | Acumed, LLC | Jan 23, 2025 | SESE |
| K242091 | Bolo Button System | Fusion Orthopedics | Dec 23, 2024 | SESE |
| K243408 | TACTIX Vector Syndesmosis System | Vilex, LLC | Nov 27, 2024 | SESE |
| K242311 | EXPERT - Flexible Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | Nov 1, 2024 | SESE |
| K240035 | TACTIX Vector Syndesmosis System | Vilex, LLC | Aug 1, 2024 | SESE |
| K240947 | TENSOR® Suture Button System | Globus Medical, Inc. | Jun 3, 2024 | SESE |
| K233531 | OIC FLEX-FIX System | Orthopaedic Implant Company | Feb 2, 2024 | SESE |
| K232780 | CC-Clip® Implant System | Cc-Instruments, Inc. | Dec 18, 2023 | SESE |
| K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | Oct 6, 2023 | SESE |
| K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | Aug 22, 2022 | SESE |
| K220947 | Arthrex Knotless AC Repair Devices | Arthrex, Inc. | Jun 6, 2022 | SESE |
| K220650 | TriMed Ripcord Device | TriMed, Inc. | Jun 1, 2022 | SESE |
| K220260 | Hercules Syndesmosis Implant System | In2bones USA, LLC | Mar 31, 2022 | SESE |
| K212990 | Acumed Ankle Syndesmosis Repair System | Acumed, LLC | Jan 7, 2022 | SESE |
| K213644 | Arthrex Knotless Mini TightRopes | Arthrex, Inc. | Dec 17, 2021 | SESE |
| K211612 | Medline UNITE REFLEX Dynamic Discs | Medline Industries, Inc. | Dec 10, 2021 | SESE |
| K200332 | EXPERT - Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | Oct 29, 2020 | SESE |
| K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | Arthrex, Inc. | Sep 3, 2020 | SESE |
| K200361 | Akros Scruture Anchor LisFranc Repair Kit | Akros Medical | Apr 6, 2020 | SESE |
| K190143 | LARS AC Band Device | Corin USA | Nov 4, 2019 | SESE |
| K190582 | MicroLink All-Suture Button Fixation System (Radiopaque) | Conmed Corporation | Jun 28, 2019 | SESE |
| K190516 | MicroLink All-Suture Button Fixation System (Radiolucent) | Conmed Corporation | Jun 28, 2019 | SESE |
| K183094 | CyclaPlex Correction System | Cycla Orthopedics, Ltd. | Apr 26, 2019 | SESE |
| K183232 | Double ENDOBUTTON Fixation Device | Smith and Nephew, Inc. | Mar 12, 2019 | SESE |
| K180243 | Infinity-Lock Button System | Xiros, Ltd. | Apr 3, 2018 | SESE |
| K171703 | PUMA System | Panther Orthopedics, Inc. | Mar 1, 2018 | SESE |
| K173550 | Akros FibuLink Syndesmosis Repair Kit | Akros Medical | Dec 14, 2017 | SESE |
| K172620 | SyndesMetrics Syndesmosis Repair System | Mortise Medical, LLC | Nov 8, 2017 | SESE |
| K170249 | GRAVITY Syndesmosis LP | Wrightmedicaltechnologyinc | Jun 30, 2017 | SESE |
| K162996 | INVISIKNOT Ankle Syndesmosis Repair Kit | Smith & Nephew, Inc. | Jun 8, 2017 | SESE |
| K170440 | KISSloc Suture System | Arthrosurface, Inc. | May 3, 2017 | SESE |
| K162805 | Akros Fibulink Syndesmosis Repair Kit | Akros Medical | Jan 10, 2017 | SESE |
| K153211 | M-Fix Acromioclavicular Device | Coracoid Solutions, Inc. | Feb 2, 2016 | SESE |
| K150359 | Tensyn Plug | Dallen Medical, Inc. | May 7, 2015 | SESE |
| K143092 | Tensyn Plug | Dallen Medical, Inc. | Feb 11, 2015 | SESE |
| K141420 | FASTFORWARD | MedShape, Inc. | Dec 18, 2014 | SESE |
| K141264 | TENSYN BAND, TENSYN FRACTURE PLATES | Dallen Medical, Inc. | Aug 21, 2014 | SESE |
| K141219 | JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS | Biomet Manufacturing Corp | Jul 18, 2014 | SESE |
| K133835 | ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM | Arthrosurface, Inc. | Jul 3, 2014 | SESE |
| K140328 | CMC MINI TIGHTROPE | Arthrex, Inc. | Mar 10, 2014 | SESE |
| K133858 | TENSYN BAND | Dallen Medical, Inc. | Feb 28, 2014 | SESE |
| K133275 | MINI TIGHTROPE | Arthrex, Inc. | Jan 30, 2014 | SESE |
| K132733 | ORTHOHELIX SYNDESMOSIS FIXATION DEVICES | Orthohelix Surgical Designs, Inc. | Jan 3, 2014 | SESE |
| K131850 | TENSYN BAND | Dallen Medical, Inc. | Nov 15, 2013 | SESE |
| K132510 | BIOPRO - INFINITY PLATE ANCHOR SYSTEM | Biopro, Inc. | Oct 24, 2013 | SESE |
| K130986 | FRAG-LOC SYSTEM | Acumed, LLC | Jul 23, 2013 | SESE |
| K112437 | ARTHREX FRACTURE SYSTEM | Arthrex, Inc. | Dec 21, 2011 | SESE |
| K112111 | ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR | Acumed, LLC | Nov 14, 2011 | SESE |
| K111032 | CMC CABLE FIX | Instratek, Inc. | Aug 31, 2011 | SESE |
| K091207 | SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE | Surgicraft , Ltd. | Feb 15, 2011 | SESE |
| K091799 | CABLE READY CABLE GRIP SYSTEM CABLE BUTTON | Zimmer, Inc. | Sep 11, 2009 | SESE |
| K091763 | MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 | Instratek, Inc. | Aug 14, 2009 | SESE |
| K090107 | MINI TIGHTROPE | Arthrex, Inc. | Aug 6, 2009 | SESE |
| K082384 | HAV-LOK BUNION CORRECTION SYSTEM | Instratek, Inc. | Dec 8, 2008 | SESE |
| K082095 | ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE | Smith & Nephew Endoscopy, Inc. | Oct 21, 2008 | SESE |
| K071978 | MINI TIGHTROPE FT REPAIR KIT | Arthrex, Inc. | Aug 15, 2007 | SESE |
| K061925 | MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS | Arthrex, Inc. | Oct 31, 2006 | SESE |
| K052776 | TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD | Arthrex, Inc. | Dec 13, 2005 | SESE |
| K043145 | BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B | Arthrex, Inc. | Feb 18, 2005 | SESE |
| K043411 | RESOFIX BIOABSORBABLE EXPANSION BOLT | Resofix, Inc. | Feb 17, 2005 | SESE |
| K043248 | TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS | Arthrex, Inc. | Feb 16, 2005 | SESE |
| K040250 | BONE-LOK HP WASHER | Triage Medical, Inc. | Mar 23, 2004 | SESE |
| K030619 | ODI 7.0MM CANNULATED SCREW SYSTEM | Orthopedic Designs, Inc. | Apr 1, 2003 | SESE |
| K023119 | BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B | Arthrex, Inc. | Dec 18, 2002 | SESE |
| K013806 | SYNTHES METALLIC SPIKED WASHERS | Synthes (Usa) | Feb 8, 2002 | SESE |
| K011583 | SPIKED WASHER | Synthes (Usa) | Jan 30, 2002 | SESE |
| K003496 | CANNULATED SCREW SYSTEM | Pioneer Surgical Technology | Feb 8, 2001 | SESE |
| K992617 | HEX BUTTON | Pioneer Surgical Technology | Oct 27, 1999 | SESE |
| K991135 | SOFT TISSUE SUTURE WASHER | Depuy, Inc. | Apr 29, 1999 | SESE |
| K983906 | DEPUY ORTHOTECH SPIKED WASHER | DePuy Orthopaedics, Inc. | Dec 18, 1998 | SESE |
| 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. | Nov 23, 1998 | SESE |
| K983265 | DEPUY ACE COMPOSITE LOCKING NUT | Depuy Ace Medical Co. | Oct 26, 1998 | SESE |
| K980944 | SYNTHES SCHUHLI IMPLANT SYSTEM | Synthes (Usa) | Apr 27, 1998 | SESE |
| K965028 | ACUMED SUTURE WASHER | Acu Med, Inc. | Mar 17, 1997 | SESE |
| K963420 | CANCELLOUS SCREW WASHER | Orthopaedic Biosystems, Ltd. | Nov 15, 1996 | SESE |
| K954682 | WASHER, BOLT, NUT, ORTHOPEDIC | Linvatec Corp. | Feb 9, 1996 | SN |
| K954148 | SUTURE WASHER | Acu Med, Inc. | Jan 17, 1996 | SESE |
| K943782 | BONE SCREW WASHER | Acu Med, Inc. | Dec 20, 1994 | SESE |
| K924455 | SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER | Synthes (Usa) | May 12, 1993 | SESE |
| K914472 | SPIKED WASHER | Synthes (Usa) | Nov 7, 1991 | SESE |
| K911306 | T-BOLT AND NUT | Danek Medical, Inc. | Sep 10, 1991 | SESE |
| K910186 | WYMAN SUTURE WASHER | Acu Med, Inc. | Jul 25, 1991 | SESE |
| K910229 | SOFT TISSUE SUTURE WASHER/3 HOLE WASHER | Depuy, Inc. | Jul 24, 1991 | SESE |
| K895107 | ACE ORTHOPAEDIC WASHERS | Buckman Co., Inc. | Sep 11, 1989 | SESE |
| K881699 | ACROMED WASHERS | Buckman Co., Inc. | Apr 27, 1988 | SESE |
| K874669 | ACE BONE SCREW NUT | Buckman Co., Inc. | Dec 11, 1987 | SESE |
| K843368 | KAPP SPINAL BUTTON | Kapp Surgical Instrument, Inc. | Sep 12, 1984 | SESE |
| K834411 | TECHMEDICA-HEWSON SHOULDER CLEAT | Techmedica, Inc. | Jan 17, 1984 | SESE |
Top Applicants
- Arthrex, Inc. — 16 clearances
- Synthes (Usa) — 5 clearances
- Dallen Medical, Inc. — 5 clearances
- Acumed, LLC — 4 clearances
- Acu Med, Inc. — 4 clearances
