MICRONAIL Distal Radius System
FDA 510(k) K150073 · Wrightmedicaltechnologyinc
510(k) numberK150073
Submission
- Device name
- MICRONAIL Distal Radius System
- Applicant
- Wrightmedicaltechnologyinc
Memphis, TN, US - Received
- January 14, 2015
- Decision date
- February 10, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | Stryker GmbH | 06/29/2026SE |
| K261651 | Precice Max System and Precice Ankle Salvage SystemHSB · Special | NuVasive Specialized Orthopedics | 06/18/2026SE |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
| K253155 | Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional | Beijing Fule Science & Technology Development… | 06/17/2026SE |
| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
| K260146 | Fitbone® Transport and Lengthening SystemHSB · Traditional | Orthofix Srl | 05/19/2026SE |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional | Orthofix Srl | 05/08/2026SE |
| K261043 | AUTOBAHN Nailing SystemHSB · Special | Globus Medical, Inc. | 04/24/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K222835 | Prophecy Preoperative Navigation Alignment SystemHSN · Traditional | 01/27/2023SE |
| K213342 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 01/05/2022SE |
| K212996 | Sterile PHALINX Hammertoe SystemHWC · Traditional | 11/16/2021SE |
| K202815 | PROPHECY Preoperative Navigation Alignment SystemHSN · Traditional | 03/10/2021SE |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemHRS · Traditional | 01/08/2021SE |
| K200507 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 10/21/2020SE |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total…HSN · Traditional | 06/08/2020SE |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle SystemHSN · Traditional | 08/22/2019SE |
| K190970 | PROSTEP TBI (Tailors Bunion Implant) SystemHWC · Traditional | 08/13/2019SE |
| K183620 | PROSTEP TBC Implant SystemHRS · Traditional | 06/06/2019SE |
Questions and answers
When was MICRONAIL Distal Radius System cleared by the FDA?
MICRONAIL Distal Radius System (K150073) received a 510(k) decision of Substantially Equivalent on February 10, 2015, 27 days after the submission was received.
What is the product code of K150073?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.