TiLink-P SI Joint Fusion System
FDA 510(k) K240720 · SurGenTec, LLC
510(k) numberK240720
Submission
- Device name
- TiLink-P SI Joint Fusion System
- Applicant
- SurGenTec, LLC
Boca Raton, FL, US - Received
- March 15, 2024
- Decision date
- April 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OUR – Sacroiliac Joint Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
sacroiliac joint fusion
Other 510(k)s with product code OUR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261381 | TiLink-L SI Joint Fusion SystemOUR · Traditional | SurGenTec, LLC | 08/24/2026SE |
| K260477 | CATAMARAN SI Joint Fusion SystemOUR · Traditional | Tenon Medical | 04/08/2026SE |
| K253488 | iFuse INTRA Ti Implant SystemOUR · Traditional | SI-BONE, Inc. | 02/11/2026SE |
| K253611 | Falco Fusion SystemOUR · Traditional | Mcnicoll Surgical, Inc. | 01/29/2026SE |
| K252834 | Sacroiliac Joint Truss System (SJTS)OUR · Traditional | 4Web Medical | 01/28/2026SE |
| K251365 | OptumSI Implant SystemOUR · Traditional | Si Solutions, LLC | 11/20/2025SE |
| K252322 | SIros-X SystemOUR · Traditional | Genesys Spine | 10/22/2025SE |
| K253094 | iFuse Bedrock Granite Implant SystemOUR · Special | SI-BONE, Inc. | 10/09/2025SE |
| K250894 | Eminent Spine Posterior SI SystemOUR · Traditional | Eminent Spine | 10/07/2025SE |
| K250647 | SImmetry+ SystemOUR · Traditional | Sivantage | 07/29/2025SE |
More from Sivantage
| 510(k) | Device | Decision |
|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | 08/26/2026SE |
| K261381 | TiLink-L SI Joint Fusion SystemOUR · Traditional | 08/24/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | 07/24/2026SE |
| K261209 | Ion-LMRW · Traditional | 06/11/2026SE |
| K260329 | Ion-C Navigation InstrumentsOLO · Traditional | 05/22/2026SE |
| K253604 | TiLink-L Navigation InstrumentsOLO · Traditional | 03/20/2026SE |
| K251714 | Ion-CMRW · Traditional | 01/16/2026SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | 07/02/2025SE |
| K243949 | OsteoFlo HydroFiberMQV · Traditional | 05/28/2025SE |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNW · Traditional | 04/24/2025SE |
Questions and answers
When was TiLink-P SI Joint Fusion System cleared by the FDA?
TiLink-P SI Joint Fusion System (K240720) received a 510(k) decision of Substantially Equivalent on April 11, 2024, 27 days after the submission was received.
What is the product code of K240720?
The FDA product code is OUR – Sacroiliac Joint Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3040.