Cleared Traditional

K121342 - XIA 4.5 SPINAL SYSTEM

K121342 is the FDA 510(k) clearance for XIA 4.5 SPINAL SYSTEM by Stryker Corp.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K121342 · Stryker Corp. · Orthopedic device
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Jun 2012
Decision
49d
Days
Class 2
Risk

K121342 is an FDA 510(k) clearance for the XIA 4.5 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 Corp. (Allendale, US). The FDA issued a Cleared decision on June 22, 2012 after a review of 49 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 Stryker Corp. devices

Submission Details

510(k) Number K121342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received May 04, 2012
Decision Date June 22, 2012
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K121342.
BEACON STABILIZATION SYSTEM
K121922 · Globus Medical, Inc. · Jul 2012
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
K121671 · Zimmer Spine, Inc. · Jul 2012
CD HORIZON SPINAL SYSTEM
K121680 · Medtronic Sofamor Danek USA, Inc. · Jul 2012
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
K111136 · Depuy Spine, Inc. · Jun 2012
REVERE 4.5 STABILIZATION SYSTEM
K113395 · Globus Medical, Inc. · Jun 2012
SYNTHES MATRIX SYSTEM
K120928 · Synthes Spine · May 2012