Cleared Special

K072183 - ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600

K072183 is an FDA 510(k) clearance for ST360 SPINAL FIXATION SYSTEM, manufactured by Zimmer Spine, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 30-day FDA review.

K072183 · Zimmer Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
30d
Days
Class 2
Risk

K072183 is an FDA 510(k) clearance for the ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600. 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 September 5, 2007 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072183

510(k) Number K072183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date September 05, 2007
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

NKB Device Classification - Class 2, Special Controls

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 914
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K072183.
EXPEDIUM SPINE SYSTEM
K070387 · Depuy Spine, Inc. · Sep 2007
MODIFICATION TO:TSRH SPINAL SYSTEM
K072317 · Medtronic Sofamor Danek USA, Inc. · Sep 2007
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K070282 · Endius, Inc. · Sep 2007
STRYKER SPINE XIA III SPINAL SYSTEM
K071373 · Stryker Spine · Aug 2007
CORAL PEDICLE SCREW SYSTEM
K070962 · Theken Spine, LLC · Aug 2007
MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
K071380 · Alphatec Spine, Inc. · Aug 2007
K072183 · ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600
Download PDF FDA Summary Zimmer Spine, Inc.