BLUE MOUNTAIN CERVICAL PLATE

K112809 · Qualgenix, LLC · KWQ · Jun 20, 2012 · Orthopedic

Device Facts

• Record ID: K112809
• Device Name: BLUE MOUNTAIN CERVICAL PLATE
• Applicant: Qualgenix, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Qualgenix Blue Mountain Cervical Plate is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). Qualgenix Blue Mountain Cervical Plate is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies with degeneration of the disc), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

Device Story

Qualgenix Blue Mountain Cervical Plate is a spinal fixation system consisting of titanium alloy plates and screws. Used by surgeons in clinical settings to provide temporary stabilization of the anterior cervical spine during interbody fusion procedures. The device is implanted to support the spine while fusion develops. It is not intended for posterior fixation. The system provides mechanical stability to the vertebral bodies, potentially benefiting patients by facilitating successful fusion and addressing conditions like trauma, deformity, or degenerative disease.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing per ASTM F1717-10 (static compression bending, dynamic compression bending, and static torsion).

Technological Characteristics

Titanium alloy (ISO 5832-3) plates and screws. Mechanical fixation device for anterior cervical spine. Tested per ASTM F1717-10.

Indications for Use

Indicated for patients requiring temporary anterior spinal stabilization during cervical fusion (C2-C7) due to degenerative disc disease, spinal stenosis, spondylolisthesis, deformity (kyphosis, lordosis, scoliosis), trauma, tumors, pseudoarthrosis, or failed previous fusions. Contraindicated for posterior element (pedicle) attachment.

Regulatory Classification

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.

Predicate Devices

• Synthes Anterior CSLP System (K000742)
• Aesculap ABC Cervical Plate (K974706, K000486)
• Theken Tether (K010466)
• DePuy DOC (K982443)
• Medtronic Orion (K042235)
• Medtronic Atlantis (K993855)
• Medtronic Zephir (K030327, K994239)
• EBI Anterior Cervical Plate (K001794)
• Spinevision C System (K012881)
• X-Spine Spider Cervical Plate (K052292)

Submission Summary (Full Text)

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K112809
page 1 of 2

JUN 2 0 2012

### 510(k) Summary

Contact:

Richard Deslauriers, M.D. CEO, Qualgenix (203) 982 - 4239

Device Trade Name:

Manufacturer:

Qualgenix Blue Mountain Cervical Plate

Qualgenix LLC 1 Jack's Hill Road (Unit 3E) Oxford, CT 06478

Date Prepared:

May 5, 2011

ll

KWQ

Spinal Fixation Device

Common Name:

Classification:

Class:

Product Code:

Indications For Use:

The Qualgenix Blue Mountain Cervical Plate is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). Qualgenix Blue Mountain Cervical Plate is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies with degeneration of the disc), spinal stenosis, spondylolisthesis, deformity {defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.

21 CFR §888.3060; Spinal intervertebral fixation orthosis

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

Device Description:

The Qualgenix Blue Mountain Cervical Plate is a system that includes titanium alloy (ISO 5832-3) plates and screws that are intended to stabilize the spine during the interbody fusion process.

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## Predicate Device(s):

The Qualgenix Blue Mountain Cervical Plate was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. The Blue Mountain Cervical Plate is substantially equivalent to the following predicate devices: Synthes Anterior CSLP System (K000742); Aesculap ABC Cervical Plate (K974706, K000486); Theken Tether (K010466); DePuy DOC (K982443); Medtronic Orion (K042235); Medtronic Atlantis (K993855); Medtronic Zephir (K030327, K994239); EBI Anterior Cervical Plate (K001794); Spinevision C System (K012881); and X-Spine Spider Cervical Plate (K052292).

#### Performance Standards:

Testing performed on this device indicates that the Qualgenix Blue Mountain Cervical Plate is substantially equivalent to predicate devices. Testing per ASTM F1717-10 included static compression bending, dynamic compression bending, and static torsion.

Conclusion:

Comparisons of device indications, intended use, design, and performance were made to predicate devices in order to determine substantial equivalence.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is simple and monochromatic.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 0 2012

Qualgenix, LLC % Dr. Richard Deslauriers CEO 1 Jack's Hill Road, Unit 3E Oxford, Connecticut 06478

Re: K112809

Trade/Device Name: Blue Mountain Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 13, 2012 Received: May 15, 2012

Dear Dr. Deslauriers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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# Page 2 - Dr. Richard Deslauriers

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K 112809

Device Name: Qualgenix Blue Mountain Cervical Plate

The Qualgenix Blue Mountain Cervical Plate is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Qualgenix Blue Mountain Cervical Plate is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies with degeneration of the disc), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

Prescription Use _ V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_ K112809