Cleared Traditional

K152681 - iFuse Implant System

K152681 is the FDA 510(k) clearance for iFuse Implant System by SI-BONE, Inc.. It is a Class 2 Orthopedic device (product code OUR) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K152681 · SI-BONE, Inc. · Orthopedic device
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Mar 2016
Decision
165d
Days
Class 2
Risk

K152681 is an FDA 510(k) clearance for the iFuse Implant System(R). Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by SI-BONE, Inc. (San Jose, US). The FDA issued a Cleared decision on March 1, 2016 after a review of 165 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

Submission Details

510(k) Number K152681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2015
Decision Date March 01, 2016
Days to Decision 165 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
43d slower than avg
Panel avg: 122d · This submission: 165d
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 118
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K152681.
PathLoc-SI Joint Fusion System
K153656 · L & K Biomed Co., Ltd. · Nov 2016
RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
K161210 · Medtronic Sofamor Danek · Aug 2016
iFUSE Implant System
K160652 · SI-BONE, Inc. · Jun 2016
The Entasis Dual-Lead Sacroiliac Implant
K152237 · Corelink, LLC · Feb 2016
iFuse Implant System
K151718 · SI-BONE, Inc. · Oct 2015
iFuse Implant System
K150875 · SI-BONE, Inc. · Jul 2015