Cleared Traditional

K211449 - Triton Sacroiliac Joint Fixation System

K211449 is an FDA 510(k) clearance for Triton Sacroiliac Joint Fixation System, manufactured by Choice Spine, LLC. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K211449 · Choice Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
113d
Days
Class 2
Risk

K211449 is an FDA 510(k) clearance for the Triton™ Sacroiliac Joint Fixation System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Choice Spine, LLC (Knoxville, US). The FDA issued a Cleared decision on August 31, 2021 after a review of 113 days - within the typical 510(k) review window.

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 Choice Spine, LLC devices

FDA 510(k) Submission Details - K211449

510(k) Number K211449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2021
Decision Date August 31, 2021
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
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 K211449.
Blue Topaz Sacroiliac Screw System
K213590 · Osseus Fusion Systems, LLC · Mar 2022
SIMPACT Sacroiliac Joint Fixation System
K212903 · Life Spine, Inc. · Dec 2021
Curiteva Sacroiliac Joint Fusion System
K210402 · Curiteva, Inc. · Sep 2021
FIREBIRD SI Fusion System
K210667 · Orthofix, Inc. · Mar 2021
Harvester SI: Sacroiliac Fixation System
K203780 · Spinus International, Inc. · Mar 2021
iFuse-TORQ™ Implant System
K203247 · SI-BONE, Inc. · Feb 2021