Cleared Special

K103287 - SYNTHES 6.0 COCR AND CPT TI-3 RODS

K103287 is an FDA 510(k) clearance for SYNTHES 6.0 COCR AND CPT TI-3 RODS, manufactured by Synthes Spine. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 65-day FDA review.

K103287 · Synthes Spine · Orthopedic device
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Jan 2011
Decision
65d
Days
Class 2
Risk

K103287 is an FDA 510(k) clearance for the SYNTHES 6.0 COCR AND CPT TI-3 RODS. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Synthes Spine (West Chester, US). The FDA issued a Cleared decision on January 5, 2011 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Synthes Spine devices

FDA 510(k) Submission Details - K103287

510(k) Number K103287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2010
Decision Date January 05, 2011
Days to Decision 65 days
Submission Type Special
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
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

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 890
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K103287.
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
K103383 · Spartek Medical, Inc. · Feb 2011
EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM
K103490 · Johnson & Johnson · Feb 2011
VEPER SYSTEM, EXPEDIUM SYSTEM
K103133 · Depuy Spine, Inc. · Jan 2011
TSRH SPINAL SYSTEM
K103049 · Medtronic Sofamor Danek · Dec 2010
VIPER SYSTEM, EXPEDIUM SYSTEM
K101993 · Depuy Spine, Inc. · Dec 2010
NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
K102514 · Nuvasive, Inc. · Dec 2010