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K Number
K062666
Device Name
VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
Manufacturer
ORTHO DEVELOPMENT CORP.
Date Cleared
2007-01-25

(140 days)

Product Code
MQP
Regulation Number
888.3060
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
Predicate For
K111965
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Vusion™ implants are intended for use in partial spine vertebrectomy procedures for vertebral body replacement. The indications include replacement of a collapsed, damaged, or unstable vertebral body that must be resected or excised due to tumor or trauma. The implants are intended for use with a supplemental rod or plate fixation system.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "Vusion™ PEEK VBR System," which is a spinal intervertebral body fixation orthosis.

This letter primarily focuses on:

  • Device Clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
  • Regulatory Information: Details about regulations (21 CFR 888.3060, Class II, Product Code: MQP).
  • Requirements: Reminding the manufacturer of general controls, registration, labeling, good manufacturing practices, etc.
  • Indications for Use: Describing the medical conditions for which the device is intended (replacement of collapsed, damaged, or unstable vertebral bodies due to tumor or trauma, used with supplemental fixation).

Therefore, I cannot provide the information requested in the format of acceptance criteria, device performance, sample sizes, ground truth, or study details, as these are not present in the given text.

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.