Cleared Traditional

K080398 - SI JOINT FUSION SYSTEM

K080398 is an FDA 510(k) clearance for SI JOINT FUSION SYSTEM, manufactured by SI-BONE, Inc.. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K080398 · SI-BONE, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2008
Decision
287d
Days
Class 2
Risk

K080398 is an FDA 510(k) clearance for the SI JOINT FUSION SYSTEM. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by SI-BONE, Inc. (Saratoga, US). The FDA issued a Cleared decision on November 26, 2008 after a review of 287 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 SI-BONE, Inc. devices

FDA 510(k) Submission Details - K080398

510(k) Number K080398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2008
Decision Date November 26, 2008
Days to Decision 287 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
165d slower than avg
Panel avg: 122d · This submission: 287d
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.