TACTIX Vector Syndesmosis System
FDA 510(k) K243408 · Vilex, LLC
510(k) numberK243408
Submission
- Device name
- TACTIX Vector Syndesmosis System
- Applicant
- Vilex, LLC
Mcminnville, TN, US - Received
- November 1, 2024
- Decision date
- November 27, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253115 | Lars AcjHTN · Traditional | Movmedix S.A.S. | 06/10/2026SE |
| K252081 | SportLinc Syndesmosis DeviceHTN · Traditional | Lincotek Medical | 03/27/2026SE |
| K253727 | Syndesmosis TightRope PROHTN · Special | Arthrex, Inc. | 12/22/2025SE |
| K251643 | Synchfix EVTHTN · Traditional | Wright Medical Technology, Inc. (Stryker… | 10/29/2025SE |
| K251134 | RipCordHTN · Traditional | TriMed, Inc. | 07/11/2025SE |
| K243624 | Acu-Sinch Knotless MiniHTN · Traditional | Acumed, LLC | 01/23/2025SE |
| K242091 | Bolo Button SystemHTN · Traditional | Fusion Orthopedics | 12/23/2024SE |
| K242311 | EXPERT - Flexible Joint Fixation SystemHTN · Traditional | GM Dos Reis Industria e Comercio Ltda. | 11/01/2024SE |
| K240035 | TACTIX Vector Syndesmosis SystemHTN · Traditional | Vilex, LLC | 08/01/2024SE |
| K240947 | TENSOR® Suture Button SystemHTN · Traditional | Globus Medical, Inc. | 06/03/2024SE |
More from Globus Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260900 | DYNEX® External Fixation SystemsKTT · Special | 04/17/2026SE |
| K250304 | TITANEX Screw SystemsHWC · Special | 03/05/2025SE |
| K240475 | Hintermann Series H2 Total Ankle SystemHSN · Traditional | 12/02/2024SE |
| K233816 | REDEMPTION Charcot Plating SystemHRS · Traditional | 08/28/2024SE |
| K240035 | TACTIX Vector Syndesmosis SystemHTN · Traditional | 08/01/2024SE |
| K231343 | Redemption Duo Hindfoot Nail SystemHSB · Traditional | 01/30/2024SE |
| K231504 | TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw SystemHWC · Traditional | 09/11/2023SE |
| K231493 | NITINEX Memory Compression StapleJDR · Traditional | 08/11/2023SE |
| K230462 | OPTIX H2 Patient Specific Instrument SystemHSN · Traditional | 07/17/2023SE |
| K230204 | ALPHALOK Plating SystemHRS · Traditional | 04/25/2023SE |
Questions and answers
When was TACTIX Vector Syndesmosis System cleared by the FDA?
TACTIX Vector Syndesmosis System (K243408) received a 510(k) decision of Substantially Equivalent on November 27, 2024, 26 days after the submission was received.
What is the product code of K243408?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.