Orthohelix Staple System
FDA 510(k) K142148 · Orthohelix Surgical Designs, Inc.
510(k) numberK142148
Submission
- Device name
- Orthohelix Staple System
- Applicant
- Orthohelix Surgical Designs, Inc.
Medina, OH, US - Received
- August 5, 2014
- Decision date
- August 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | Arthrex, Inc. | 09/01/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | Paragon 28, Inc. | 08/06/2026SE |
| K250712 | Linkt Compression Staple SystemJDR · Traditional | Trax Surgical | 05/14/2025SE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | Medline Industries, LP | 04/11/2025SE |
| K243742 | Arthrex DynaNite Nitinol StaplesJDR · Traditional | Arthrex, Inc. | 01/31/2025SE |
| K243658 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 12/26/2024SE |
| K242415 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 09/06/2024SE |
| K240212 | COGNiTiON Staple SystemJDR · Special | Ortho Solutions UK , Ltd. | 02/23/2024SE |
| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional | Novastep | 12/04/2023SE |
More from Novastep
| 510(k) | Device | Decision |
|---|---|---|
| K141004 | Intraosseous Fixation SystemHTY · Special | 08/21/2014SE |
| K141301 | Maxlock Extreme Elbow Fracture SystemHRS · Traditional | 07/11/2014SE |
| K132733 | Orthohelix Syndesmosis Fixation DevicesHTN · Traditional | 01/03/2014SE |
| K132591 | Maxlock Extreme SystemHRS · Special | 09/17/2013SE |
| K130832 | Orthohelix Staple SystemJDR · Traditional | 08/15/2013SE |
| K131324 | Maxtorque Screw SystemHWC · Traditional | 05/31/2013SE |
| K123203 | Maxlock Extreme System Model MXLHRS · Traditional | 12/14/2012SE |
| K122005 | Maxlock Extreme SystemHRS · Special | 09/06/2012SE |
| K121437 | Mini Maxlock Extreme Plating SystemHRS · Special | 06/13/2012SE |
| K120165 | Intraosseous Fixation SystemHTY · Traditional | 04/17/2012SE |
Questions and answers
When was Orthohelix Staple System cleared by the FDA?
Orthohelix Staple System (K142148) received a 510(k) decision of Substantially Equivalent on August 21, 2014, 16 days after the submission was received.
What is the product code of K142148?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.