Cleared Traditional

K232149 - BowTie SI Joint Fusion System

K232149 is an FDA 510(k) clearance for BowTie SI Joint Fusion System, manufactured by Sail Fusion, LLC. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K232149 · Sail Fusion, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
276d
Days
Class 2
Risk

K232149 is an FDA 510(k) clearance for the BowTie™ SI Joint Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Sail Fusion, LLC (Del Mar, US). The FDA issued a Cleared decision on April 20, 2024 after a review of 276 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 Sail Fusion, LLC devices

FDA 510(k) Submission Details - K232149

510(k) Number K232149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2023
Decision Date April 20, 2024
Days to Decision 276 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 122d · This submission: 276d
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 119
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K232149.
ARx® SAI Implant System
K241464 · Life Spine, Inc. · Jul 2024
iFuse TORQ® Implant System
K241574 · SI-BONE, Inc. · Jul 2024
Eminent Spine SI Screw System
K240505 · Eminent Spine, LLC · Jun 2024
Patriot-SI Posterior Implant System
K232259 · Spinal Simplicity, LLC · Apr 2024
TiLink-P SI Joint Fusion System
K240720 · SurGenTec, LLC · Apr 2024
Camber Sacroiliac (SI) Fixation System
K233972 · Camber Spine Technologies · Feb 2024