Cleared Traditional

K201538 - Life Spine SIMPACT Sacroiliac Joint Fixation System

K201538 is an FDA 510(k) clearance for Life Spine SIMPACT Sacroiliac Joint Fix..., manufactured by Life Spine, Inc.. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K201538 · Life Spine, Inc. · Orthopedic device
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Sep 2020
Decision
101d
Days
Class 2
Risk

K201538 is an FDA 510(k) clearance for the Life Spine SIMPACT Sacroiliac Joint Fixation System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on September 18, 2020 after a review of 101 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 Life Spine, Inc. devices

FDA 510(k) Submission Details - K201538

510(k) Number K201538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2020
Decision Date September 18, 2020
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
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 K201538.
Advanced Research Medical Trident SI Screw System
K203373 · Advanced Research Medical, LLC · Jan 2021
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K203671 · Medacta International S.A. · Jan 2021
FIREBIRD SI Fusion System
K203138 · Orthofix, Inc. · Nov 2020
FIREBIRD SI Fusion System
K201664 · Orthofix, Inc. · Sep 2020
NADIA SI Fusion System
K190580 · Ilion Medical, Inc. · Aug 2020
SI-Restore Sacroiliac Joint Fixation System
K200868 · Biofusion Medical · Apr 2020