Cleared Traditional

K120091 - R&D INNOVATION PEDICLE SCREW SYSTEM

K120091 is an FDA 510(k) clearance for R&D INNOVATION PEDICLE SCREW SYSTEM, manufactured by R&D Innovation, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K120091 · R&D Innovation, LLC · Orthopedic device
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May 2012
Decision
128d
Days
Class 2
Risk

K120091 is an FDA 510(k) clearance for the R&D INNOVATION PEDICLE SCREW SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by R&D Innovation, LLC (Colorado Springs, US). The FDA issued a Cleared decision on May 18, 2012 after a review of 128 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 R&D Innovation, LLC devices

FDA 510(k) Submission Details - K120091

510(k) Number K120091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2012
Decision Date May 18, 2012
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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 747
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K120091.
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
K111136 · Depuy Spine, Inc. · Jun 2012
REVERE 4.5 STABILIZATION SYSTEM
K113395 · Globus Medical, Inc. · Jun 2012
STAINLESS STEEL SPINAL SYSTEM
K120829 · Theken Spine, LLC · May 2012
SYNTHES MATRIX SYSTEM
K120928 · Synthes Spine · May 2012
SYNTHES USS CONNECTOR
K120571 · Synthes Spine · May 2012
VIPER SYSTEM
K121020 · Depuy Spine, Inc. · May 2012