Cleared Traditional

K120714 - PICASSO MIS SPINAL FIXATION SYSTEM

K120714 is an FDA 510(k) clearance for PICASSO MIS SPINAL FIXATION SYSTEM, manufactured by Accel Spine. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K120714 · Accel Spine · Orthopedic device
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Aug 2012
Decision
154d
Days
Class 2
Risk

K120714 is an FDA 510(k) clearance for the PICASSO MIS SPINAL FIXATION SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Accel Spine (Dallas, US). The FDA issued a Cleared decision on August 9, 2012 after a review of 154 days - an extended review cycle.

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 Accel Spine devices

FDA 510(k) Submission Details - K120714

510(k) Number K120714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2012
Decision Date August 09, 2012
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To 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 - NKB Thoracolumbosacral Pedicle Screw System

All 731
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K120714.
NUVASIVE POLYAXIAL SPINAL SCREWS
K121619 · Nuvasive, Inc. · Aug 2012
CD HORIZON SPINAL SYSTEM
K121764 · Medtronic Sofamor Danek, Inc. · Aug 2012
LANX SPINAL FIXATION SYSTEM
K122145 · Lanx, Inc. · Aug 2012
NAUTILUS SPINAL SYSTEM
K111953 · Life Spine · Aug 2012
LANX SPINAL FIXATION SYSTEM
K121940 · Lanx, Inc. · Aug 2012
SYNTHES MATRIX SYSTEM
K120838 · Synthes Spine · Jul 2012