Sbi K-Wires
FDA 510(k) K051605 · Small Bone Innovations, LLC
510(k) numberK051605
Submission
- Device name
- Sbi K-Wires
- Applicant
- Small Bone Innovations, LLC
Morrisville, PA, US - Received
- June 16, 2005
- Decision date
- August 10, 2005
- 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
Other 510(k)s with product code HTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | Paragon 28, Inc. | 08/28/2026SE |
| 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 |
|---|---|---|
| K130147 | Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)HSB · Special | 05/03/2013SE |
| K112982 | Anatomic Ankle Arthrodesis Interlocking NAIL(A3 Interlocking Nail )HSB · Traditional | 04/02/2012SE |
| K102180 | Rhead Radial Head Extended StemsJDB · Traditional | 12/20/2010SE |
| K092754 | Sbi Foot and Ankle Cannulated Screw System, Model 100-0061HWC · Traditional | 01/19/2010SE |
| K093550 | Mini Rail External Fixator SystemKTT · Special | 01/07/2010SE |
| K073635 | Sbi SR MTP Toe ImplantKWD · Traditional | 03/19/2008SE |
| K071541 | Sbi TwistofixHWC · Traditional | 09/10/2007SE |
| K063635 | Sbi Forefoot SetHWC · Traditional | 08/29/2007SE |
| K071656 | Sbi ArtfixHWC · Traditional | 08/27/2007SE |
| K071540 | Sbi Titanium Threaded PinJDW · Traditional | 08/08/2007SE |
Questions and answers
When was Sbi K-Wires cleared by the FDA?
Sbi K-Wires (K051605) received a 510(k) decision of Substantially Equivalent on August 10, 2005, 55 days after the submission was received.
What is the product code of K051605?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.