Cleared Traditional

K231923 - Liberty SI Lateral Implant System

K231923 is an FDA 510(k) clearance for Liberty SI Lateral Implant System, manufactured by Spinal Simplicity, LLC. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K231923 · Spinal Simplicity, LLC · Orthopedic device
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Dec 2023
Decision
158d
Days
Class 2
Risk

K231923 is an FDA 510(k) clearance for the Liberty SI Lateral Implant System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Spinal Simplicity, LLC (Overland Park, US). The FDA issued a Cleared decision on December 5, 2023 after a review of 158 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 Spinal Simplicity, LLC devices

FDA 510(k) Submission Details - K231923

510(k) Number K231923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2023
Decision Date December 05, 2023
Days to Decision 158 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
36d slower than avg
Panel avg: 122d · This submission: 158d
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 K231923.
PathLoc SI Joint Fusion System
K240201 · L & K Biomed Co., Ltd. · Feb 2024
iFuse Bedrock Granite® Implant System
K233508 · SI-BONE, Inc. · Jan 2024
TORPEDO Implant System®
K230817 · Deltacor GmbH · Jan 2024
SOLACE Sacroiliac Fixation System
K233241 · Ht Medical, LLC Dba Xenix Medical · Oct 2023
REUNION Sacroiliac Joint Fusion System
K232211 · Astura Medical · Oct 2023
TransLoc 3D
K232878 · Foundation Fusion Solutions, LLC (Dba Cornerloc) · Oct 2023