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.
Recent Cleared Devices (20 of 92)
Showing 20 most recent of 92 cleared devices.
| 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 |
Top Applicants
- Arthrex, Inc. — 16 clearances
- Dallen Medical, Inc. — 5 clearances
- Synthes (Usa) — 5 clearances
- Acu Med, Inc. — 4 clearances
- Acumed, LLC — 4 clearances
