Stryker SonicPin System
FDA 510(k) K170418 · Stryker Trauma GmbH
510(k) numberK170418
Submission
- Device name
- Stryker SonicPin System
- Applicant
- Stryker Trauma GmbH
Schoenkirchen, DE - Received
- February 13, 2017
- Decision date
- June 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K252657 | Impact PEEK Union Nail SystemHTY · Special | Nvision Biomedical Technologies, Inc. | 09/19/2025SE |
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| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | Nvision Biomedical Technologies | 06/11/2025SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
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| K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…HSB · Special | 06/11/2019SE |
| K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…HSB · Traditional | 06/06/2018SE |
| K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemHSB · Traditional | 01/12/2018SE |
| K172210 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…KWS · Traditional | 10/02/2017SE |
| K153154 | Asnis JFX SystemHWC · Traditional | 12/28/2015SE |
| K151178 | VariAx 2 Wrist Fusion SystemHRS · Traditional | 06/24/2015SE |
| K143063 | Stryker SonicPin System, Stryker SonicAnchor SystemHTY · Traditional | 01/27/2015SE |
| K143138 | AxSOS 3 Ti Locking Plate SystemHRS · Traditional | 12/22/2014SE |
Questions and answers
When was Stryker SonicPin System cleared by the FDA?
Stryker SonicPin System (K170418) received a 510(k) decision of Substantially Equivalent on June 20, 2017, 127 days after the submission was received.
What is the product code of K170418?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.