Cleared Traditional

REFORM PEDICLE SCREW SYSTEM (K130279) - FDA 510(k) Clearance

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

K130279 · Spinal USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
135d
Days
Class 2
Risk

K130279 is an FDA 510(k) clearance for the REFORM PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Spinal USA (Colorado Springs, US). The FDA issued a Cleared decision on June 20, 2013 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Spinal USA devices

Submission Details

510(k) Number K130279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2013
Decision Date June 20, 2013
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 18
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K130279.
EXACTECH GIBRALT SPINAL SYSTEM
K110197 · Exactech, Inc. · Jul 2011
MODIFICATION TO S4 SPINAL SYSTEM
K060152 · Aesculap, Inc. · Feb 2006
S4 SPINAL SYSTEM
K050979 · Aesculap, Inc. · Jul 2005
CD HORIZON SPINAL SYSTEM
K050981 · Medtronic Sofamor Danek USA, Inc. · May 2005
STRYKER SPINE OASYS SYSTEM
K032394 · Howmedica Osteonics Corp. · Feb 2004
CD HORIZON SPINAL SYSTEM
K031655 · Medtronic Sofamor Danek USA, Inc. · Jun 2003