Cleared Traditional

K042571 - STRYKER SPINE AVS TL PEEK SPACER

K042571 is the FDA 510(k) clearance for STRYKER SPINE AVS TL PEEK SPACER by Stryker Spine. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K042571 · Stryker Spine · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2005
Decision
143d
Days
Class 2
Risk

K042571 is an FDA 510(k) clearance for the STRYKER SPINE AVS TL PEEK SPACER. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on February 11, 2005 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 K042571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2004
Decision Date February 11, 2005
Days to Decision 143 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
21d slower than avg
Panel avg: 122d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 161
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K042571.
XPAND CORPECTOMY SPACER
K050850 · Globus Medical, Inc. · May 2005
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
K051000 · Spinal Concepts, Inc. · May 2005
STRYKER SPINE AVS PL PEEK SPACER
K050624 · Stryker Spine · Apr 2005
NUVASIVE COROENT SYSTEM
K043405 · Nuvasive, Inc. · Feb 2005
PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)
K043206 · Pioneer Surgical Technology · Jan 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043566 · Medtronic Sofamor Danek · Jan 2005