Cleared Traditional

K051296 - SIJF CANNULATED SCREW SYSTEM

K051296 is the FDA 510(k) clearance for SIJF CANNULATED SCREW SYSTEM by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code OUR) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K051296 · Depuy Spine, Inc. · Orthopedic device
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Aug 2005
Decision
100d
Days
Class 2
Risk

K051296 is an FDA 510(k) clearance for the SIJF CANNULATED SCREW SYSTEM. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on August 26, 2005 after a review of 100 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 Depuy Spine, Inc. devices

Submission Details

510(k) Number K051296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2005
Decision Date August 26, 2005
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
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 102
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K051296.
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
LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM
K141246 · Life Spine, Inc. · Feb 2015
SI-FIX SACROILIAC JOINT FUSION SYSTEM
K110472 · Medtronic Sofamor Danek · May 2012