Liberty Anterior Cervical Plate

K172585 · Valorus Spine · KWQ · Oct 23, 2017 · Orthopedic

Device Facts

• Record ID: K172585
• Device Name: Liberty Anterior Cervical Plate
• Applicant: Valorus Spine
• Product Code: KWQ · Orthopedic
• Decision Date: Oct 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Liberty Anterior Cervical Plate System is interior screw fixation of the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: - degenerative disc disease (as defined by neck pain of discogenic origin with the degeneration of the disc confirmed by patient history and radiographic studies), - spondylolisthesis. - trauma (i.e. fractures or dislocations), - tumors. - deformity (i.e. kyphosis, lordosis or scoliosis), - pseudarthrosis. - failed previous fusion, - spinal stenosis

Device Story

Liberty Anterior Cervical Plate System; mechanical spinal fixation device. Consists of cervical plates (10-100mm) and self-drilling/self-tapping bone screws (4.0-4.5mm diameter). Used by surgeons via anterior approach to stabilize cervical spine (C2-T1) during fusion. Plates feature graft visualization holes for intraoperative monitoring. Device provides temporary stabilization to facilitate bone fusion; benefits patient by maintaining alignment and structural integrity during healing process. Used in clinical/OR settings.

Clinical Evidence

No clinical data. Bench testing only: static and dynamic compression and static torsion testing performed per ASTM F1717.

Technological Characteristics

Spinal intervertebral body fixation orthosis. Materials similar to predicate devices. Components: cervical plates (10-100mm) and bone screws (4.0-4.5mm). Mechanical fixation via self-drilling/self-tapping screws. Testing performed per ASTM F1717 standards for static/dynamic compression and static torsion.

Indications for Use

Indicated for skeletally mature patients requiring temporary anterior screw fixation of the cervical spine (C2-T1) as an adjunct to fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, failed previous fusion, and spinal stenosis.

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

• Anterior Cervical Plate System / Osteomed Implantes, LTDA (K151553)
• ACLP System / Synthes Spine (K031276)
• Blackstone™ “Classic” Anterior Cervical Plate / Blackstone Medical, Inc. (K022965)

Submission Summary (Full Text)

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Valorus Spine % Mr. Nick Cordaro CEO Watershed Idea Foundry 533 2nd Street Encinitas, California 92024 October 23, 2017

Re: K172585

Trade/Device Name: Liberty Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: August 24, 2017 Received: August 28, 2017

Dear Mr. Cordaro:

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 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 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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 (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K172585

Device Name Liberty Anterior Cervical Plate System

#### Indications for Use (Describe)

The Liberty Anterior Cervical Plate System is interior screw fixation of the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

- degenerative disc disease (as defined by neck pain of discogenic origin with the degeneration of the disc confirmed by patient history and radiographic studies),

- spondylolisthesis.

- trauma (i.e. fractures or dislocations),
- tumors.
- deformity (i.e. kyphosis, lordosis or scoliosis),
- pseudarthrosis.
- failed previous fusion,
- spinal stenosis

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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# 510(k) Summary

# DATE PREPARED

August 24, 2017

## MANUFACTURER AND 510(k) OWNER

Valorus Spine 696 San Ramon Valley Blvd., Suite 411, Danville CA 94526, USA Telephone: [phone] Fax: [phone] Official Contact: Leah Fero, VP Engineering

## REPRESENTATIVE/CONSULTANT

Nicholas M. Cordaro Watershed Ideas Foundry Telephone: Email: [e-mail]

#### PROPRIETARY NAME OF SUBJECT DEVICE

Liberty Anterior Cervical Plate

#### COMMON NAME

Anterior Cervical Plate

#### DEVICE CLASSIFICATION

Spinal intervertebral body fixation orthosis (21 CFR 888.3060, Product Code KWQ, Class II)

Orthopedic Panel

#### INDICATIONS FOR USE

The Liberty Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

- degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis,
- trauma (i.e. fractures or dislocations),
- tumors,
- deformity (defined as kyphosis, lordosis, or scoliosis),

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- pseudarthrosis,
- failed previous fusion,
- spinal stenosis

# DEVICE DESCRIPTION

The Liberty Anterior Cervical Plate is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-drilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (10 mm – 100 mm), addressing multiple levels of fixation (one to five). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in two diameters (4.0 mm, and 4.5 mm) and a variety of lengths (10 mm - 18 mm).

# PREDICATE DEVICE IDENTIFICATION

The Liberty Anterior Cervical Plate is substantially equivalent to the following predicates:

| 510(k)<br>Number | Predicate Device Name / Manufacturer | Primary<br>Predicate |
|------------------|--------------------------------------------------------------------------|----------------------|
| K151553 | Anterior Cervical Plate System / Osteomed Implantes, LTDA | ✓ |
| K031276 | ACLP System / Synthes Spine | |
| K022965 | Blackstone™ “Classic” Anterior Cervical Plate / Blackstone Medical, Inc. | |

# SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the Liberty Anterior Cervical Plate. The following tests were performed to demonstrate safety based on current industry standards:

- . Static and dynamic compression (per ASTM F1717)
- . Static torsion (per ASTM F1717)

The results of these tests indication that the Liberty Anterior Cervical Plate is substantially equivalent to the predicate devices.

# EQUIVALENCE TO PREDICATE DEVICES

Valorus believes that the Liberty Anterior Cervical Plate is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design and dimensions, and uses similar or identical materials as the devices cleared in K151553, K031276, and K022965. The subject device has the same intended use and similar technological characteristics to the devices cleared in K151553 and K022965. The device has similar instrumentation to the device cleared in K151553, and K031276.

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# CONCLUSION

The Liberty Anterior Cervical Plate is considered substantially equivalent to the predicate devices based on the testing performed, the identical indications for use, and similar technological characteristics. Based on the testing performed, including static and dynamic compression as well as static torsion (per ASTM F1717), it can be concluded that that the subject device is as safe and as effective compared to the predicate devices.