HRX · Arthroscope
Orthopedic · 21 CFR 888.1100 · Class 2
Overview
| Product Code | HRX |
|---|---|
| Device Name | Arthroscope |
| Regulation | 21 CFR 888.1100 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| 3rd-Party Reviewable | Yes |
Identification
An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
Classification Rationale
(1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Recent Cleared Devices (20 of 680)
Showing 20 most recent of 680 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253523 | Freedom DS Decompression System | Spinal Simplicity | Apr 16, 2026 | SESE |
| K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | Mar 12, 2026 | SESE |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) | Dec 23, 2025 | SESE |
| K250795 | PUREVUE FMS | W.O.M. World of Medicine GmbH | Dec 5, 2025 | SESE |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | Nov 21, 2025 | SESE |
| K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | Nov 3, 2025 | SESE |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | Oct 15, 2025 | SESE |
| K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | Sep 29, 2025 | SESE |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | Aug 27, 2025 | SESE |
| K241990 | SpineSite Endoscope System | Hydrocision, Inc. | Jul 30, 2025 | SESE |
| K243602 | Arthrex Spine Endoscope | Arthrex, Inc. | May 16, 2025 | SESE |
| K242417 | VECTR Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC | Dec 11, 2024 | SESE |
| K243020 | MIDASVu | Intravu, Inc. | Dec 2, 2024 | SESE |
| K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | May 6, 2024 | SESE |
| K240535 | Digital ClarusScope System; Digital NeuroPEN System | Clarus Medical, LLC | Apr 25, 2024 | SESE |
| K233675 | FMS VUE Fluid Management and Tissue Debridement System | DePuy Mitek, Inc. | Feb 26, 2024 | SESE |
| K233115 | Hawkeye Control Unit with Eyas Endoscope | E Surgical, LLC | Feb 6, 2024 | SESE |
| K223709 | Kyphoplasty Balloon Catheter | Jiangsu Changmei Medtech Co., Ltd. | Aug 16, 2023 | SESE |
| K221142 | Kyphoplasty Balloon System | OK Medinet Korea Co., Ltd. | Apr 21, 2023 | SESE |
| K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | Hemodia Sas | Mar 9, 2023 | SESE |
Top Applicants
- KARL STORZ Endoscopy-America, Inc. — 28 clearances
- Arthrex, Inc. — 27 clearances
- Acufex Microsurgical, Inc. — 26 clearances
- Linvatec Corp. — 19 clearances
- Smith & Nephew, Inc. — 18 clearances
