Bionx Distal Radius Screw
FDA 510(k) K974876 · Bionx Implants, Inc.
510(k) numberK974876
Submission
- Device name
- Bionx Distal Radius Screw
- Applicant
- Bionx Implants, Inc.
Washington, DC, US - Received
- December 29, 1997
- Decision date
- March 20, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K252022 | OSSIOfiber® Interference ScrewMAI · Traditional | OSSIO , Ltd. | 08/19/2025SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | OSSIO , Ltd. | 05/27/2025SE |
| K250544 | Knotilus+ Biocomposite Knotless AnchorMAI · Traditional | Stryker Endoscopy | 05/23/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K030388 | Impact Suture Anchor. Model 433510HWC · Traditional | 04/24/2003SE |
| K023022 | Nugen FX ScrewHWC · Special | 10/04/2002SE |
| K020056 | Duet Suture AnchorHWC · Traditional | 06/26/2002SE |
| K011569 | Biosorbfx O/M 2.0/2/4 SystemJEY · Traditional | 02/22/2002SE |
| K013546 | Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214HWC · Special | 11/21/2001SE |
| K013057 | Biocuff,C, Models 236018, 236028, 236036MAI · Special | 10/12/2001SE |
| K012334 | Contour Meniscus Arrow, Models 541110, 541113, and 541116MAI · Special | 09/19/2001SE |
| K012001 | SmartscrewHWC · Special | 07/18/2001SE |
| K012000 | 1.5MM Bone Fixation KitHWC · Special | 07/18/2001SE |
| K010983 | Plla PinHTY · Special | 06/13/2001SE |
Questions and answers
When was Bionx Distal Radius Screw cleared by the FDA?
Bionx Distal Radius Screw (K974876) received a 510(k) decision of Substantially Equivalent on March 20, 1998, 81 days after the submission was received.
What is the product code of K974876?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.