SportLinc Syndesmosis Device
FDA 510(k) K252081 · Lincotek Medical
510(k) numberK252081
Submission
- Device name
- SportLinc Syndesmosis Device
- Applicant
- Lincotek Medical
Bartlett, TN, US - Received
- July 2, 2025
- Decision date
- March 27, 2026
- 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
Other 510(k)s with product code HTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253115 | Lars AcjHTN · Traditional | Movmedix S.A.S. | 06/10/2026SE |
| 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 |
| 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 |
|---|---|---|
| K250764 | SpineLinc Anterior Cervical Implant SystemODP · Traditional | 12/05/2025SE |
Questions and answers
When was SportLinc Syndesmosis Device cleared by the FDA?
SportLinc Syndesmosis Device (K252081) received a 510(k) decision of Substantially Equivalent on March 27, 2026, 268 days after the submission was received.
What is the product code of K252081?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.