Modification to Smartpin
FDA 510(k) K041288 · Linvatec Biomaterials, Inc.
510(k) numberK041288
Submission
- Device name
- Modification to Smartpin
- Applicant
- Linvatec Biomaterials, Inc.
Tampere, FI - Received
- May 13, 2004
- Decision date
- June 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K250315 | Ronavis FX (FX-001)HTY · Traditional | AIRS, Inc. | 08/01/2025SE |
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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 |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
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| K052080 | Matryx Interference ScrewHWC · Special | 08/25/2005SE |
| K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…MAI · Special | 11/19/2004SE |
| K042517 | Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsJEY · Special | 10/08/2004SE |
| K042295 | Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020HWC · Special | 09/16/2004SE |
| K032894 | Osteo Acl Screw MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…HWC · Traditional | 05/07/2004SE |
| K032447 | Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedHWC · Special | 04/16/2004SE |
| K031981 | 2.4 Smartnail, Models 532416, 532425, 532435, 532445MAI · Special | 07/25/2003SE |
Questions and answers
When was Modification to Smartpin cleared by the FDA?
Modification to Smartpin (K041288) received a 510(k) decision of Substantially Equivalent on June 10, 2004, 28 days after the submission was received.
What is the product code of K041288?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.