Cleared Traditional

K091946 - VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091946 · Stryker Spine · Orthopedic device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Sep 2009

Decision

87d

Days

Class 2

Risk

K091946 is an FDA 510(k) clearance for the VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816X.... 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 September 25, 2009 after a review of 87 days - a notably fast clearance cycle.

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: 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 Spine devices

Submission Details

510(k) Number	K091946 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 30, 2009
Decision Date	September 25, 2009
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

35d faster than avg

Panel avg: 122d · This submission: 87d

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.