Newdeal K Wire
FDA 510(k) K022599 · New Deal, S.A.
510(k) numberK022599
Submission
- Device name
- Newdeal K Wire
- Applicant
- New Deal, S.A.
Potomac, MD, US - Received
- August 5, 2002
- Decision date
- October 30, 2002
- 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 |
|---|---|---|
| K070241 | Modification to Lapidus PlateHRS · Special | 02/08/2007SE |
| K070160 | Modification to TTC PlatesHRS · Special | 02/08/2007SE |
| K063820 | Lisfranc PlateHRS · Special | 02/08/2007SE |
| K060474 | Lisfranc PlateHRS · Traditional | 08/03/2006SE |
| K061765 | Kalix II ImplantHWC · Special | 07/18/2006SE |
| K061594 | Large Uni-Clip StapleJDR · Special | 07/03/2006SE |
| K060476 | Lapidus PlateHRS · Traditional | 05/17/2006SE |
| K060473 | TTC PlateHRS · Traditional | 05/17/2006SE |
| K053093 | Kalix II Implant, Model 141 0XX with XXHWC · Special | 12/07/2005SE |
| K052152 | B-Bop PlateHRS · Traditional | 09/13/2005SE |
Questions and answers
When was Newdeal K Wire cleared by the FDA?
Newdeal K Wire (K022599) received a 510(k) decision of Substantially Equivalent on October 30, 2002, 86 days after the submission was received.
What is the product code of K022599?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.