NEOPLATE SPINE ANTERIOR FIXATION SYSTEM

K132653 · Neoortho Productos Orthopedicos S/A · KWQ · May 14, 2014 · Orthopedic

Device Facts

• Record ID: K132653
• Device Name: NEOPLATE SPINE ANTERIOR FIXATION SYSTEM
• Applicant: Neoortho Productos Orthopedicos S/A
• Product Code: KWQ · Orthopedic
• Decision Date: May 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NeoOrtho NEOPLATE Spine Anterior Fixation System is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma, (including fractures), 3) tumors, 4) deformity (defined by kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Note: this device system is intended for anterior cervical intervertebral body fusions only.

Device Story

NEOPLATE Spine Anterior Fixation System consists of titanium alloy bone plates and screws used for anterior cervical interbody fixation. System provides temporary stabilization during cervical spinal fusion. Operated by surgeons in clinical/surgical settings. Device components are implanted into the vertebral body via an anterior approach. Performance relies on mechanical stability provided by the plate-screw construct. Benefits include stabilization of the spine to facilitate fusion in patients with degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, or failed prior fusions.

Clinical Evidence

Bench testing only. Mechanical testing performed according to ASTM F1717, including compression, fatigue, and static torsional testing.

Technological Characteristics

Titanium alloy (ASTM F136). Plate and screw fixation system. Mechanical performance tested per ASTM F1717. No software or electronic components.

Indications for Use

Indicated for temporary stabilization of the anterior cervical spine during fusion in patients with degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, or failed previous fusions. Contraindicated for screw attachment to posterior elements (pedicles) of cervical, thoracic, or lumbar spine.

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

• Zephir Anterior Cervical System (K030327)

Submission Summary (Full Text)

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| 510(k) Summary | MAY 1 4 2014 |
|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | NEOPLATE Spine Anterior Fixation System |
| 510(K) Number | K132653 |
| Date Prepared | May 12, 2014 |
| Submitter | NEOORTHO Produtos Ortopedicos S/A<br>Rua Angelo Domingos Durigan 607,<br>Cascatinha<br>Curitiba-PR, Brazil 82020-340 |
| | Telephone: [phone]<br>Fax: [phone] |
| Official Contact | Tara Conrad<br>TechLink International Consulting<br>18851 NE 29th Avenue Suite 720<br>Aventura, FL 33180<br>TEL- [phone] |
| Common Name<br>Trade Name<br>Regulatory Class<br>Product Code<br>Classification Panel<br>Regulation Numbers<br>Predicate Device | Appliance, fixation, spinal Intervertebral body<br>NEOPLATE Spine Anterior Fixation System<br>Class II<br>KWQ<br>Orthopedic<br>21 CFR § 888.3060<br>K030327 Zephir Anterior Cervical System by<br>Medtronic Sofamor Danek |

# Device Description

The NeoOrtho NEOPLATE Spine Anterior Fixation System consists of a variety of shapes and sizes of bone plates, screws and instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

### Indications for Use Statement

The NeoOrtho NEOPLATE Spine Anterior Fixation System is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma, (including fractures), 3) tumors, 4) deformity (defined by kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

Note: this device system is intended for anterior cervical intervertebral body fusions only.

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Image /page/1/Picture/0 description: The image shows the logo for "NEOORTHO". The logo consists of a stylized, abstract symbol on the left, resembling a curved shape within a square. To the right of the symbol is the word "NEOORTHO" in bold, sans-serif font. The overall design is simple and modern.

Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

# Material

The NEOPLATE is manufactured from titanium alloy as described in ASTM F136.

# Performance Data

Mechanical testing was performed according to ASTM F1717. The specific tests performed were:

- Compression Testing .
- Fatique Testing .
- Static Torsional Testing .

The mechanical testing results demonstrate substantial equivalence to other legally marketed devices.

# Technological Characteristics

The NEOPLATE System possesses the same technological characteristics as the predicate device. These include:

- Performance (described above) .
- . Basic design (plate and screw system)
- Material (titanium alloy) .
- . Size (dimensions are within the ranges of the predicate)

Therefore the fundamental scientific technology of the NEOPLATE System is the same as the previously cleared device.

#### Conclusion

The subject device and predicate device share the same indications for use, primary implant design and equivalent material of manufacture. In conclusion, the information provided and performance testing conducted demonstrate that the subject device is substantially equivalent to other legally marketed devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, with three curved lines representing the body and a base that suggests movement or support.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 14, 2014

NEOORTHO Produtos Orthopedicos S/A % TechLink International Consulting Ms. Tara Conrad Regulatory Affairs Manager 18851 Northeast 29th Avenue, Suite 720 Aventura, Florida 33180

Re: K132653

Trade/Device Name: NEOPLATE Spine Anterior Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 4, 2014 Received: April 11, 2014

Dear Ms. Conrad:

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.

1f 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 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

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Page 2 - Ms. Tara Conrad

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K132653

Device Name

NEOPLATE Spine Anterior Fixation System

#### Indications for Use (Describe)

The NeoOrtho NEOPLATE Spine Anterior Fixation System is interior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is incdicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma, (including fractures), 3) tumors, 4)deformity (defined by kyphosis, or scoliosis), 5) nseudarthrosis, and/or 6) failed previous fusions. Note: this device system is intended for anterior cervical intervertebral body fusions only.

Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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