TITAN Nail; APTUS K-Wire System
FDA 510(k) K260934 · Medartis AG
510(k) numberK260934
Submission
- Device name
- TITAN Nail; APTUS K-Wire System
- Applicant
- Medartis AG
Basel, CH - Received
- March 20, 2026
- Decision date
- April 17, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260761 | APTUS Clavicle System 2.8HRS · Traditional | 06/05/2026SE |
| 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 |
| K230971 | APTUS® 3.5 TriLock Straight PlatesHRS · Traditional | 06/02/2023SE |
Questions and answers
When was TITAN Nail; APTUS K-Wire System cleared by the FDA?
TITAN Nail; APTUS K-Wire System (K260934) received a 510(k) decision of Substantially Equivalent on April 17, 2026, 28 days after the submission was received.
What is the product code of K260934?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.