Cleared Traditional

K082572 - USS ILIOSACRAL

K082572 is the FDA 510(k) clearance for USS ILIOSACRAL by Synthes Spine. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K082572 · Synthes Spine · Orthopedic device
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Nov 2008
Decision
80d
Days
Class 2
Risk

K082572 is an FDA 510(k) clearance for the USS ILIOSACRAL, USS POLYAXIAL. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Synthes Spine (West Chester, US). The FDA issued a Cleared decision on November 24, 2008 after a review of 80 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 Synthes Spine devices

Submission Details

510(k) Number K082572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2008
Decision Date November 24, 2008
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
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 K082572.
REVOLVE STABILIZATION SYSTEM
K083416 · Globus Medical, Inc. · Jan 2009
CLAMPFIX
K082914 · Synthes Spine · Dec 2008
MERCURY SPINAL SYSTEM
K083230 · Spinal Elements, Inc. · Dec 2008
TSRH SPINAL SYSTEM
K081080 · Medtronic Sofamor Danek · Nov 2008
MODIFICATION TO: NUVASIVE SPHERX II SYSTEM
K083028 · Nuvasive, Inc. · Nov 2008
MODFICATION TO: EXPEDIUM SPINE SYSTEM
K082942 · Depuy Spine, Inc. · Oct 2008