Cleared Traditional

K133291 - ST360 DEGREES SPINAL FIXATION SYSTEM

K133291 is the FDA 510(k) clearance for ST360 DEGREES SPINAL FIXATION SYSTEM by Zimmer Spine, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K133291 · Zimmer Spine, Inc. · Orthopedic device
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Dec 2013
Decision
53d
Days
Class 2
Risk

K133291 is an FDA 510(k) clearance for the ST360 DEGREES SPINAL FIXATION SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Zimmer Spine, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 17, 2013 after a review of 53 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 Zimmer Spine, Inc. devices

Submission Details

510(k) Number K133291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date December 17, 2013
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
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 K133291.
TIGER SPINE SYSTEM
K133369 · Corelink, LLC · Jan 2014
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K132878 · Medacta International · Dec 2013
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K133188 · Stryker Spine · Dec 2013
CD HORIZON SPINAL SYSTEM
K132328 · Medtronic Sofamor Danek USA, Inc. · Dec 2013
TITLE 2 POLYAXIAL SPINAL SYSTEM
K133086 · Zimmer Spine, Inc. · Nov 2013
CD HORIZON SPINAL SYSTEM
K132639 · Medtronic Sofamor Danek USA, Inc. · Nov 2013