Cleared Traditional

K103292 - TRIO TRAUMA SPINAL SYSTEM

K103292 is an FDA 510(k) clearance for TRIO TRAUMA SPINAL SYSTEM, manufactured by Stryker Corporation. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K103292 · Stryker Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
116d
Days
Class 2
Risk

K103292 is an FDA 510(k) clearance for the TRIO TRAUMA 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 Corporation (Allendale, US). The FDA issued a Cleared decision on March 4, 2011 after a review of 116 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 Corporation devices

FDA 510(k) Submission Details - K103292

510(k) Number K103292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2010
Decision Date March 04, 2011
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 890
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K103292.
LANX SPINAL SYSTEM
K103237 · Lanx, Inc. · Mar 2011
REVERE SACRAL PLATES
K103072 · Globus Medical, Inc. · Mar 2011
QUANTUM SPINAL SYSTEM, QUANTUM MIS
K101790 · Pioneer Surgical Technology · Mar 2011
LAGUNA PEDICLE SCREW SYSTEM
K103748 · Phygen, LLC · Mar 2011
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
K103383 · Spartek Medical, Inc. · Feb 2011
EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM
K103490 · Johnson & Johnson · Feb 2011