Cleared Traditional

K052054 - TSRH SPINAL SYSTEM

K052054 is the FDA 510(k) clearance for TSRH SPINAL SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K052054 · Medtronic Sofamor Danek · Orthopedic device
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Aug 2005
Decision
18d
Days
Class 2
Risk

K052054 is an FDA 510(k) clearance for the TSRH 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 Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on August 16, 2005 after a review of 18 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 Medtronic Sofamor Danek devices

Submission Details

510(k) Number K052054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2005
Decision Date August 16, 2005
Days to Decision 18 days
Submission Type Traditional
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
104d faster than avg
Panel avg: 122d · This submission: 18d
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 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K052054.
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K052609 · Medtronic Sofamor Danek · Oct 2005
TSRH SPINAL SYSTEM
K052144 · Medtronic Sofamor Danek · Aug 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K052187 · Medtronic Sofamor Danek · Aug 2005
CD HORIZON SPINAL SYSTEM
K051674 · Medtronic Sofamor Danek USA, Inc. · Jul 2005
EXPEDIUM SPINE SYSTEM
K051024 · Depuy Spine, Inc. · Jul 2005
CD HORIZON SPINAL SYSTEM
K050439 · Medtronic Sofamor Danek, Inc. · Mar 2005