Cleared Special

K240720 - TiLink-P SI Joint Fusion System

K240720 is the FDA 510(k) clearance for TiLink-P SI Joint Fusion System by SurGenTec, LLC. It is a Class 2 Orthopedic device (product code OUR) cleared through the Special 510(k) pathway after a 27-day FDA review.

K240720 · SurGenTec, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
27d
Days
Class 2
Risk

K240720 is an FDA 510(k) clearance for the TiLink-P SI Joint Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on April 11, 2024 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all SurGenTec, LLC devices

Submission Details

510(k) Number K240720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2024
Decision Date April 11, 2024
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 105
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K240720.
Eminent Spine SI Screw System
K240505 · Eminent Spine, LLC · Jun 2024
BowTie™ SI Joint Fusion System
K232149 · Sail Fusion, LLC · Apr 2024
Patriot-SI Posterior Implant System
K232259 · Spinal Simplicity, LLC · Apr 2024
Camber Sacroiliac (SI) Fixation System
K233972 · Camber Spine Technologies · Feb 2024
PathLoc SI Joint Fusion System
K240201 · L & K Biomed Co., Ltd. · Feb 2024
iFuse Bedrock Granite® Implant System
K233508 · SI-BONE, Inc. · Jan 2024