Aptus K-Wire System
FDA 510(k) K092038 · Medartis AG
510(k) numberK092038
Submission
- Device name
- Aptus K-Wire System
- Applicant
- Medartis AG
San Diego, CA, US - Received
- July 6, 2009
- Decision date
- September 23, 2009
- 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 |
|---|---|---|
| K260761 | APTUS Clavicle System 2.8HRS · Traditional | 06/05/2026SE |
| K260934 | TITAN Nail; APTUS K-Wire SystemHWC · Special | 04/17/2026SE |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5HRS · Traditional | 03/16/2026SE |
| K243610 | APTUS Hand System; APTUS Elbow Dorsal OlecranonHRS · Traditional | 03/07/2025SE |
| K240613 | APTUS Elbow Dorsal Olecranon PlatesHRS · Traditional | 06/20/2024SE |
| K232105 | APTUS Foot System 2.8-3.5HRS · Traditional | 04/19/2024SE |
| K234062 | APTUS Hand Scaphoid PlatesHRS · Traditional | 03/21/2024SE |
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionHWC · Traditional | 11/03/2023SE |
| K232324 | StealthFix Intraosseous Fixation SystemJDR · Special | 08/30/2023SE |
| K232144 | Sterile Products of the APTUS SystemHRS · Special | 08/18/2023SE |
Questions and answers
When was Aptus K-Wire System cleared by the FDA?
Aptus K-Wire System (K092038) received a 510(k) decision of Substantially Equivalent on September 23, 2009, 79 days after the submission was received.
What is the product code of K092038?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.