Cleared Traditional

UCR SPINAL SYSTEM (K043232) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043232 · Seaspine · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2004
Decision
29d
Days
Class 2
Risk

K043232 is an FDA 510(k) clearance for the UCR 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 Seaspine (Vista, US). The FDA issued a Cleared decision on December 21, 2004 after a review of 29 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 Seaspine devices

Submission Details

510(k) Number K043232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2004
Decision Date December 21, 2004
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 438
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K043232.
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K043488 · Medtronic Sofamor Danek · Mar 2005
MODIFICATION TO TSRH SPINAL SYSTEM
K050282 · Medtronic Sofamor Danek · Feb 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043321 · Medtronic Sofamor Danek · Feb 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042962 · Medtronic Sofamor Danek · Dec 2004
MODIFICATION TO PROTEX STABILIZATION SYSTEM
K042953 · Globus Medical, Inc. · Nov 2004
CD HORIZON SPINAL SYSTEM
K042886 · Medtronic Sofamor Danek · Nov 2004