Cleared Abbreviated

K030087 - SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K030087 · Spinal Concepts, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2003
Decision
189d
Days
Class 2
Risk

K030087 is an FDA 510(k) clearance for the SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Spinal Concepts, Inc. (Austin, US). The FDA issued a Cleared decision on July 17, 2003 after a review of 189 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Spinal Concepts, Inc. devices

Submission Details

510(k) Number K030087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2003
Decision Date July 17, 2003
Days to Decision 189 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 122d · This submission: 189d
Pathway characteristics
Standards-based clearance path.

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 895
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K030087.
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K260786 · S.M.A.I.O · Apr 2026