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K Number
K132332
Device Name
MOUNTAINEER OCT SPINAL SYSTEM
Manufacturer
MEDOS INTERNATIONAL SARL
Date Cleared
2013-08-22

(27 days)

Product Code
KWP,MNI
Regulation Number
888.3050
Type
Special
Panel
OR
Reference & Predicate Devices
K041203,K042508,K080828,K110353
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MOUNTAINEER OCT Spinal System is intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), and is indicated for the following:

  • DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
  • Spondylolisthesis
  • Spinal stenosis
  • Fracture/dislocation
  • Atlanto/axial fracture with instability
  • Occipitocervical dislocation
  • Revision of previous cervical spine surgery
  • Tumors

The occipital bone screws are limited to occipital fixation only.

The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The SONGER® wire/cable system to be used with the MOUNTAINEER OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.

The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM systems using the dual wedding band and axial connectors, and via dual diameter rods.

Device Description

The MOUNTAINEER® OCT Spinal System consists of plates, nuts, bone screws, rods, transverse rod connectors, lateral offset connectors, head-to-head connectors, cable connectors, dual wedding band and axial connectors, set screws, minipolyaxial screws, monoaxial screws, hooks, and SONGER® Cables. The components are manufactured from Titanium Alloy.

The MOUNTAINEER® OCT Spinal System Longitudinal rods are also available in cobalt-chromium-molybdenum alloy conforming to ASTM F-1537. Cobaltchromium-molybdenum alloy rods are intended for use with titanium components only.

AI/ML Overview

The provided text does not describe the acceptance criteria for a device, nor does it detail a study proving the device meets acceptance criteria in the manner requested.

This document is a 510(k) summary for the MOUNTAINEER® OCT Spinal System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria.

Specifically, it states:

  • "Performance data is not provided in this submission."
  • "The Substantial Equivalence Justification demonstrates that the devices are as safe, as effective, and perform as well as the predicate devices."

Therefore, I cannot extract the requested information to fill in the table and answer the study-related questions. The device's approval is based on its similarity to existing, cleared devices, and not on new performance data provided in this particular submission.

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.