Cleared Special

K183071 - VLIFT-s Vertebral Body Replacement System

K183071 is an FDA 510(k) clearance for VLIFT-s Vertebral Body Replacement System, manufactured by Stryker Spine. The device is a Class 2 Orthopedic device with product code PLR cleared through the Special 510(k) pathway after a 66-day FDA review.

K183071 · Stryker Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
66d
Days
Class 2
Risk

K183071 is an FDA 510(k) clearance for the VLIFT-s Vertebral Body Replacement System. Classified as Spinal Vertebral Body Replacement Device - Cervical (product code PLR), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on January 10, 2019 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K183071

510(k) Number K183071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2018
Decision Date January 10, 2019
Days to Decision 66 days
Submission Type Special
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
Modification to existing cleared device.

PLR Device Classification - Class 2, Special Controls

Product Code PLR Spinal Vertebral Body Replacement Device - Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
Definition Vertebral Body Replacement In The Cervical Spine.
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 - PLR Spinal Vertebral Body Replacement Device - Cervical

All 18
Devices cleared under the same product code (PLR) and FDA review panel - the closest regulatory comparables to K183071.
ALTA Anterior Cervical Corpectomy System
K190426 · Astura Medical, LLC · Oct 2019
Omnia Medical VBR
K191778 · Omnia Medical, LLC · Aug 2019
Normandy VBR System
K191423 · Zavation Medical Products, LLC · Aug 2019
NuVasive Monolith Cervical Corpectomy System
K180550 · Nu Vasive, Incorporated · Nov 2018
Trabis
K173893 · Coligne AG · Sep 2018
Normandy VBR System
K180673 · Zavation Medical Products, LLC · Jul 2018
K183071 · VLIFT-s Vertebral Body Replacement System
Download PDF FDA Summary Stryker Spine