Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260
FDA 510(k) K003659 · Bionx Implants, Inc.
510(k) numberK003659
Submission
- Device name
- Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260
- Applicant
- Bionx Implants, Inc.
Tampere, FI - Received
- November 28, 2000
- Decision date
- February 20, 2001
- 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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| K253325 | ZipToe Hammertoe Fusion SystemHTY · Traditional | Toetal Solutions | 12/29/2025SE |
| K252657 | Impact PEEK Union Nail SystemHTY · Special | Nvision Biomedical Technologies, Inc. | 09/19/2025SE |
| K250315 | Ronavis FX (FX-001)HTY · Traditional | AIRS, Inc. | 08/01/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | OrthoPediatrics Corp. | 06/24/2025SE |
| 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 |
More from OSSIO , Ltd.
| 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 Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 cleared by the FDA?
Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 (K003659) received a 510(k) decision of Substantially Equivalent on February 20, 2001, 84 days after the submission was received.
What is the product code of K003659?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.