Synchfix EVT
FDA 510(k) K251643 · Wright Medical Technology, Inc. (Stryker Corporation)
510(k) numberK251643
Submission
- Device name
- Synchfix EVT
- Applicant
- Wright Medical Technology, Inc. (Stryker Corporation)
Memphis, TN, US - Received
- May 29, 2025
- Decision date
- October 29, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
| 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 |
| 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 |
| K243408 | TACTIX Vector Syndesmosis SystemHTN · Special | Vilex, LLC | 11/27/2024SE |
| 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 |
|---|---|---|
| K253159 | Prophecy Incompass Surgical Planning SystemHSN · Traditional | 06/16/2026SE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | 09/30/2025SE |
| K250037 | Incompass Total Ankle SystemHSN · Traditional | 06/20/2025SE |
| K241999 | Prophecy Surgical Planning SystemHSN · Traditional | 11/01/2024SE |
Questions and answers
When was Synchfix EVT cleared by the FDA?
Synchfix EVT (K251643) received a 510(k) decision of Substantially Equivalent on October 29, 2025, 153 days after the submission was received.
What is the product code of K251643?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.