Cleared Traditional

K081080 - TSRH SPINAL SYSTEM

K081080 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 219-day FDA review.

K081080 · Medtronic Sofamor Danek · Orthopedic device
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Nov 2008
Decision
219d
Days
Class 2
Risk

K081080 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 November 21, 2008 after a review of 219 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Sofamor Danek devices

Submission Details

510(k) Number K081080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2008
Decision Date November 21, 2008
Days to Decision 219 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
97d slower than avg
Panel avg: 122d · This submission: 219d
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 K081080.
CLAMPFIX
K082914 · Synthes Spine · Dec 2008
MERCURY SPINAL SYSTEM
K083230 · Spinal Elements, Inc. · Dec 2008
USS ILIOSACRAL, USS POLYAXIAL
K082572 · Synthes Spine · Nov 2008
MODIFICATION TO: NUVASIVE SPHERX II SYSTEM
K083028 · Nuvasive, Inc. · Nov 2008
MODFICATION TO: EXPEDIUM SPINE SYSTEM
K082942 · Depuy Spine, Inc. · Oct 2008
BLACKSTONE PEDICLE SCREW SYSTEM
K082797 · Blackstone Medical, Inc. · Oct 2008