Arthroscopic Retention-Manipulation System (Arms)
FDA 510(k) K873619 · Arthropedics, Inc.
510(k) numberK873619
Submission
- Device name
- Arthroscopic Retention-Manipulation System (Arms)
- Applicant
- Arthropedics, Inc.
Wallington, NJ, US - Received
- September 8, 1987
- Decision date
- January 14, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HRX – Arthroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.1100
- Specialty
- Orthopedic
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code HRX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260203 | Fule Vertebroplasty Balloon CatheterHRX · Traditional | Beijing Fule Science & Technology Development… | 08/28/2026SE |
| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | Karl Storz SE & CO. KG | 08/26/2026SE |
| K252790 | Digital ClarusScope System and Digital NeuroPEN SystemHRX · Traditional | Clarus Medical, LLC | 05/26/2026SE |
| K253523 | Freedom DS Decompression SystemHRX · Traditional | Spinal Simplicity | 04/16/2026SE |
| K252546 | VantageTM Lumbar Decompression KitHRX · Traditional | Allevion Medical, LLC | 03/12/2026SE |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…HRX · Traditional | Medimaging Integrated Solution, Inc (Miis) | 12/23/2025SE |
| K250795 | Purevue FMSHRX · Traditional | W.O.M. World of Medicine GmbH | 12/05/2025SE |
| K252666 | Articulator Arthroscopic BurHRX · Traditional | Joint Preservation Innovations, LLC | 11/21/2025SE |
| K252458 | Kyphoplasty Balloon Dilatation CathetersHRX · Traditional | Shanghai Lange Medtech Co., Ltd. | 11/03/2025SE |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHRX · Traditional | Hand Biomechanics Lab, Inc. | 10/15/2025SE |
More from Hand Biomechanics Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873655 | Monopolar Cautery Retrogade Tip #TM-1703JOS · Traditional | 12/15/1987SE |
| K873654 | Monopolar Cautery Conical Tip #TM-1702JOS · Traditional | 12/15/1987SE |
| K873653 | Monopolar Cautery Blade Tip #TM-1701JOS · Traditional | 12/15/1987SE |
| K873387 | Video Arthroscope, 1.7MM X 55 MMHXR · Traditional | 11/25/1987SE |
| K873714 | Banana Knife, Disposable #TM-1612HTS · Traditional | 11/02/1987SE |
| K873713 | Triangular Knife, Disposable #TM-1611HTS · Traditional | 11/02/1987SE |
| K873711 | Retrograde Knife, Disposable #TM-1613HTS · Traditional | 11/02/1987SE |
| K873710 | Magnetic Retriever, 1.7MM W/Luer Fitting TM-1350HWB · Traditional | 11/02/1987SE |
| K873652 | Hook Probe #TM-1376HXB · Traditional | 11/02/1987SE |
| K873651 | Blunt Measuring Probe W/2MM Gradations #TM-1375HXB · Traditional | 11/02/1987SE |
Questions and answers
When was Arthroscopic Retention-Manipulation System (Arms) cleared by the FDA?
Arthroscopic Retention-Manipulation System (Arms) (K873619) received a 510(k) decision of Substantially Equivalent on January 14, 1988, 128 days after the submission was received.
What is the product code of K873619?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.