Shotel Ankle Arthrodesis Nail System
FDA 510(k) K163627 · Biopro, Inc.
510(k) numberK163627
Submission
- Device name
- Shotel Ankle Arthrodesis Nail System
- Applicant
- Biopro, Inc.
Port Huron, MI, US - Received
- December 22, 2016
- Decision date
- September 14, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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| 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 |
|---|---|---|
| K162674 | BioPro Foot Plating SystemsHRS · Traditional | 06/16/2017SE |
| K132510 | Biopro - Infinity Plate Anchor SystemHTN · Traditional | 10/24/2013SE |
| K130298 | Biopro Kwick-Wire Universal Screw SystemJDW · Traditional | 06/18/2013SE |
| K121973 | Biopro Hemi-Edge Toe SystemKWD · Traditional | 10/30/2012SE |
| K100761 | Biopro Polar HeadKWY · Traditional | 12/03/2010SE |
| K101030 | Modification to HBS Headless Bone ScrewHWC · Special | 06/03/2010SE |
| K090208 | Biopro Femoral HeadsJDI · Traditional | 05/22/2009SE |
| K083490 | Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685HTY · Traditional | 03/18/2009SE |
| K082705 | Biopro Bipolar Head, Models 18130-18152KWY · Traditional | 12/15/2008SE |
| K081149 | Biopro Go-Ez ScrewHWC · Traditional | 08/05/2008SE |
Questions and answers
When was Shotel Ankle Arthrodesis Nail System cleared by the FDA?
Shotel Ankle Arthrodesis Nail System (K163627) received a 510(k) decision of Substantially Equivalent on September 14, 2017, 266 days after the submission was received.
What is the product code of K163627?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.