Cleared Traditional

K230857 - TiLink-P SI Joint Fusion System

K230857 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 Traditional 510(k) pathway after a 180-day FDA review.

K230857 · SurGenTec, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Sep 2023
Decision
180d
Days
Class 2
Risk

K230857 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 September 25, 2023 after a review of 180 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all SurGenTec, LLC devices

FDA 510(k) Submission Details - K230857

510(k) Number K230857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2023
Decision Date September 25, 2023
Days to Decision 180 days
Submission Type Traditional
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
58d slower than avg
Panel avg: 122d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 130
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K230857.
REUNION Sacroiliac Joint Fusion System
K232211 · Astura Medical · Oct 2023
TransLoc 3D
K232878 · Foundation Fusion Solutions, LLC (Dba Cornerloc) · Oct 2023
Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System
K232605 · Lesspine Innovations · Sep 2023
Integrity-SI® Fusion System
K230226 · OsteoCentric Technologies · Sep 2023
CATAMARAN SI Joint Fusion System
K231944 · Tenon Medical, Inc. · Aug 2023
Xenix Medical Sacroiliac Fixation System
K231829 · Ht Medical D.B.A. Xenix Medical · Aug 2023