Cleared Traditional

K162133 - VerteFIT Corpectomy Cage System

K162133 is an FDA 510(k) clearance for VerteFIT Corpectomy Cage System, manufactured by Ldr Spine USA, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K162133 · Ldr Spine USA, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
288d
Days
Class 2
Risk

K162133 is an FDA 510(k) clearance for the VerteFIT Corpectomy Cage System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Ldr Spine USA, Inc. (Austin, US). The FDA issued a Cleared decision on May 16, 2017 after a review of 288 days - an extended review 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: 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.

FDA 510(k) Submission Details - K162133

510(k) Number K162133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2016
Decision Date May 16, 2017
Days to Decision 288 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
166d slower than avg
Panel avg: 122d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

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 278
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K162133.
Omnia Medical VBR
K172323 · Omnia Medical, LLC · Oct 2017
Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
K171686 · Choicespine · Sep 2017
CAPRI Corpectomy Cage System
K171704 · K2m · Aug 2017
CAPRI Corpectomy Cage System
K170055 · K2m · Apr 2017
NuVasive(r) Monolith Corpectomy System
K170271 · Nu Vasive, Incorporated · Mar 2017
Rectangular Corpectomy Cage
K152460 · Amendia, Inc. · Dec 2015