Cleared Traditional

K071373 - STRYKER SPINE XIA III SPINAL SYSTEM

K071373 is the FDA 510(k) clearance for STRYKER SPINE XIA III SPINAL SYSTEM by Stryker Spine. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K071373 · Stryker Spine · Orthopedic device
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Aug 2007
Decision
103d
Days
Class 2
Risk

K071373 is an FDA 510(k) clearance for the STRYKER SPINE XIA III 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 Stryker Spine (Allendale, US). The FDA issued a Cleared decision on August 27, 2007 after a review of 103 days - within the typical 510(k) review window.

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 Stryker Spine devices

Submission Details

510(k) Number K071373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2007
Decision Date August 27, 2007
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
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 K071373.
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
ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600
K072183 · Zimmer Spine, Inc. · Sep 2007
MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
K071380 · Alphatec Spine, Inc. · Aug 2007
MODIFICATION TO: VIPER SPINE SYSTEM
K071860 · Depuy Spine, Inc. · Aug 2007
DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM
K070631 · Stryker Spine · Jul 2007