Manufacturer
SurGenTec, LLCTiLink-L Navigation Instruments
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K253604
- Device name
- TiLink-L Navigation Instruments
- Company
- SurGenTec, LLC
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2025-11-18
- Decision date
- 2026-03-20
- Submission type
- Traditional
- Technology type
- Stereotactic Surgery(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Navigation System
- Classification source
- AI classified
Indications for Use
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The TiLink-L Navigation Instruments are intended to be used with the TiLink-L Joint Fusion System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. Fluoroscopy is intended to be used for navigating final implant placement.
Intended Use
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The TiLink-L Navigation Instruments are intended to be used with the TiLink-L Joint Fusion System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. Fluoroscopy is intended to be used for navigating final implant placement.
Device Description
The TiLink-L Navigation Instruments include a Drill Bit, Drill Guide, and Inserter and are specifically designed to be used with the TiLink-L Joint Fusion System Implants. The TiLink-L Navigation Instruments are to be used with the NavLock Instruments and Medtronic StealthStation System S8. The TiLink-L Joint Fusion System is provided sterile (single use) and non-sterile (reusable) and the TiLink-L Navigation Instruments are manufactured from Stainless Steel per ASTM F899.
Summary parsed at:2026-06-19 04:30:47 UTC