Speed, Speed Shift, Speed Titan, Speed Arc
FDA 510(k) K142292 · Biomedical Enterprises, Inc.
510(k) numberK142292
Submission
- Device name
- Speed, Speed Shift, Speed Titan, Speed Arc
- Applicant
- Biomedical Enterprises, Inc.
San Antonio, TX, US - Received
- August 18, 2014
- Decision date
- November 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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| 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 |
|---|---|---|
| K153573 | ConvergeHRS · Traditional | 08/11/2016SE |
| K150125 | Elite Nitinol Fixation SystemJDR · Traditional | 05/11/2015SE |
| K143023 | Nitinol Compression Plating SystemHRS · Traditional | 01/16/2015SE |
| K133270 | Speed ArcJDR · Traditional | 04/17/2014SE |
| K133520 | Hammerlock 2HTY · Traditional | 01/09/2014SE |
| K124022 | Speed ShiftJDR · Traditional | 05/14/2013SE |
| K061385 | Osstaple, Ossplate, OssforceKWQ · Traditional | 05/30/2007SE |
| K023488 | Osstaple, CraniofacialJEY · Special | 10/31/2002SE |
| K023486 | Osstaple, MaxillofacialJEY · Special | 10/31/2002SE |
Questions and answers
When was Speed, Speed Shift, Speed Titan, Speed Arc cleared by the FDA?
Speed, Speed Shift, Speed Titan, Speed Arc (K142292) received a 510(k) decision of Substantially Equivalent on November 17, 2014, 91 days after the submission was received.
What is the product code of K142292?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.