Cleared Traditional

K070368 - TRIO PLATE SYSTEM

K070368 is the FDA 510(k) clearance for TRIO PLATE SYSTEM by Stryker Corp.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K070368 · Stryker Corp. · Orthopedic device
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May 2007
Decision
85d
Days
Class 2
Risk

K070368 is an FDA 510(k) clearance for the TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ 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 May 4, 2007 after a review of 85 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 K070368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2007
Decision Date May 04, 2007
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 K070368.
QUANTUM SPINAL SYSTEM
K070973 · Pioneer Surgical Technology · Jul 2007
MODIFICATIONS TO CD HORIZON SPINAL SYSTEM
K063670 · Medtronic Sofamor Danek · Jun 2007
ARX-LINK CROSS CONNECTOR
K070995 · Life Spine · Jun 2007
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K070367 · Endius, Inc. · Apr 2007
MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
K070551 · Pioneer Surgical Technology · Mar 2007
MODIFICATION TO S4 SPINAL SYSTEM
K062327 · Aesculap, Inc. · Mar 2007