Cleared Traditional

K240526 - POWEReam Xia/Serrato

K240526 is the FDA 510(k) clearance for POWEReam Xia/Serrato by Stryker Instruments. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K240526 · Stryker Instruments · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
66d
Days
Class 2
Risk

K240526 is an FDA 510(k) clearance for the POWEReam Xia/Serrato. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Stryker Instruments (Portage, US). The FDA issued a Cleared decision on April 29, 2024 after a review of 66 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 Instruments devices

Submission Details

510(k) Number K240526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2024
Decision Date April 29, 2024
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
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 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K240526.
Vector™ Pedicle Screw System
K241276 · Innovasis, Inc. · May 2024
JAZZ Spinal System
K240392 · Implanet · May 2024
Salvo® Spine System
K240685 · Spine Wave, Inc. · May 2024
Erisma® Deformity Spinal System
K240872 · Clariance · Apr 2024
CarboClear® Hybrid Pedicle Screw System
K240846 · CarboFix Orthopedics , Ltd. · Apr 2024
NewPort Spinal System
K232566 · SeaSpine Orthopedics Corporation · Apr 2024