Cleared Traditional

K141246 - LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141246 · Life Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
284d
Days
Class 2
Risk

K141246 is an FDA 510(k) clearance for the LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Life Spine, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on February 22, 2015 after a review of 284 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 Life Spine, Inc. devices

Submission Details

510(k) Number K141246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2014
Decision Date February 22, 2015
Days to Decision 284 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
162d slower than avg
Panel avg: 122d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K141246.
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