Cleared Special

K243835 - TiLink-P SI Joint Fusion System

K243835 is an FDA 510(k) clearance for TiLink-P SI Joint Fusion System, manufactured by SurGenTec, LLC. The device is a Class 2 Orthopedic device with product code OUR cleared through the Special 510(k) pathway after a 14-day FDA review.

K243835 · SurGenTec, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
14d
Days
Class 2
Risk

K243835 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 December 27, 2024 after a review of 14 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.

FDA 510(k) Submission Details - K243835

510(k) Number K243835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2024
Decision Date December 27, 2024
Days to Decision 14 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
108d faster than avg
Panel avg: 122d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

OUR Device Classification - Class 2, Special Controls

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 132
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K243835.
Catamaran SI Joint Fusion System
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TiLink-P Joint Fusion System
K242414 · SurGenTec, LLC · Nov 2024
TiLink-P SI Joint Fusion System
K242141 · SurGenTec, LLC · Aug 2024
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K241504 · SI-BONE, Inc. · Aug 2024
K243835 · TiLink-P SI Joint Fusion System
Download PDF FDA Summary SurGenTec, LLC