Cleared Traditional

K053276 - IST PEDICLE SCREW SYSTEM

K053276 is an FDA 510(k) clearance for IST PEDICLE SCREW SYSTEM, manufactured by Innovative Spinal Technologies, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K053276 · Innovative Spinal Technologies, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2005
Decision
34d
Days
Class 2
Risk

K053276 is an FDA 510(k) clearance for the IST 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 Innovative Spinal Technologies, Inc. (Mansfield, US). The FDA issued a Cleared decision on December 27, 2005 after a review of 34 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Innovative Spinal Technologies, Inc. devices

FDA 510(k) Submission Details - K053276

510(k) Number K053276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2005
Decision Date December 27, 2005
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
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 751
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K053276.
CD HORIZON SPINAL SYSTEM
K053474 · Medtronic Sofamor Danek · Jan 2006
CD HORIZON SPINAL SYSTEM
K053101 · Medtronic Sofamor Danek · Jan 2006
TANGORS POLYAXIAL SYSTEM
K052385 · Ulrich GmbH & Co. KG · Dec 2005
SYNTHES PANGEA MONOAXIAL SYSTEM
K052151 · Synthes Spine Co.Lp · Dec 2005
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
K052747 · Medtronic Sofamor Danek · Oct 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K052609 · Medtronic Sofamor Danek · Oct 2005