4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur PLUS/4MM Barrel Tornado Bur Plus, 4MM & 5MM Aggressive Blade Plus
FDA 510(k) K131191 · Depuy Mitek, A Johnson & Johnson Company
510(k) numberK131191
Submission
- Device name
- 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur PLUS/4MM Barrel Tornado Bur Plus, 4MM & 5MM Aggressive Blade Plus
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
Raynham, MA, US - Received
- April 26, 2013
- Decision date
- July 22, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| 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.
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| K140896 | Vapr Arctic Suction ElectrodeGEI · Traditional | 08/05/2014SE |
| K141259 | Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon PEEK…MAI · Special | 06/10/2014SE |
| K133794 | 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…MAI · Traditional | 02/04/2014SE |
| K132241 | Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…MAI · Traditional | 11/05/2013SE |
| K130814 | Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMMBI · Traditional | 08/01/2013SE |
| K131974 | Healix Advance Knotless BR Anchor (6.5MM)MAI · Special | 07/25/2013SE |
| K130912 | Omnicut Resection BladeHRX · Traditional | 06/14/2013SE |
| K130917 | Healix Advance Knotless BR AnchorMAI · Traditional | 05/24/2013SE |
Questions and answers
When was 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur PLUS/4MM Barrel Tornado Bur Plus, 4MM & 5MM Aggressive Blade Plus cleared by the FDA?
4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur PLUS/4MM Barrel Tornado Bur Plus, 4MM & 5MM Aggressive Blade Plus (K131191) received a 510(k) decision of Substantially Equivalent on July 22, 2013, 87 days after the submission was received.
What is the product code of K131191?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.