Cleared Special

K082797 - BLACKSTONE PEDICLE SCREW SYSTEM

K082797 is the FDA 510(k) clearance for BLACKSTONE PEDICLE SCREW SYSTEM by Blackstone Medical, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 24-day FDA review.

K082797 · Blackstone Medical, Inc. · Orthopedic device
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Oct 2008
Decision
24d
Days
Class 2
Risk

K082797 is an FDA 510(k) clearance for the BLACKSTONE 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 Blackstone Medical, Inc. (Wayne, US). The FDA issued a Cleared decision on October 17, 2008 after a review of 24 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 Blackstone Medical, Inc. devices

Submission Details

510(k) Number K082797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2008
Decision Date October 17, 2008
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K082797.
TSRH SPINAL SYSTEM
K081080 · Medtronic Sofamor Danek · Nov 2008
MODIFICATION TO: NUVASIVE SPHERX II SYSTEM
K083028 · Nuvasive, Inc. · Nov 2008
MODFICATION TO: EXPEDIUM SPINE SYSTEM
K082942 · Depuy Spine, Inc. · Oct 2008
CD HORIZON SPINAL SYSTEM
K082236 · Medtronic Sofamor Danek · Oct 2008
NUVASIVE SPHERX SYSTEM
K082332 · Nuvasive, Inc. · Oct 2008
RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601
K082608 · Stryker Spine · Oct 2008