VERTA Corpectomy Cage

K143490 · Camber Spine · MQP · Jan 26, 2015 · Orthopedic

Device Facts

• Record ID: K143490
• Device Name: VERTA Corpectomy Cage
• Applicant: Camber Spine
• Product Code: MQP · Orthopedic
• Decision Date: Jan 26, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VERTA Corpectomy Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The device is intended for use with bone graft and with supplemental fixation systems (such as anterior plating systems, or posterior screw systems) cleared for use in the spine.

Device Story

Vertebral body replacement device; provides structural stability in thoracolumbar spine following corpectomy or vertebrectomy. Load-bearing frame with hollow center; serrated superior/inferior surfaces grip vertebral endplates to resist expulsion. Implanted by surgeons in clinical settings; requires supplemental fixation (e.g., anterior plates, posterior screws) and bone graft. Benefits patient by restoring spinal column height and structural support during fusion process.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including static/dynamic compression, static/dynamic torsion, subsidence, and expulsion tests per ASTM standards.

Technological Characteristics

Implant material: PEEK (ASTM F2026) with tantalum markers (ASTM F560). Accessories: 17-4 Stainless Steel (ASTM F899-11). Form factor: Load-bearing frame with hollow center and serrated surfaces. Sterilization: Non-sterile, autoclaveable (SAL 10^-6 per ISO 17665).

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma-induced collapse, damage, or instability.

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

• NIKO Corpectomy Spacer (K072465)

Submission Summary (Full Text)

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

January 26, 2015

Camber Spine Technologies Mr. Daniel A. Pontecorvo President & CEO 418 East Lancaster Avenue Wayne, Pennsylvania 19087

Re: K143490

Trade/Device Name: VERTA Corpectomy Cage Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: December 8, 2014 Received: December 8, 2014

Dear Mr. Pontecorvo:

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

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Page 2 - Mr. Daniel A. Pontecorvo

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/Resourcesfor You/Industry/default.htm. 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 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 vours.

## Lori A. Wiggins -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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### Indications for Use

510(k) Number (if known) K143490

Device Name VERTA Corpectomy Cage

#### Indications for Use (Describe)

The VERTA Corpectomy Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-LS) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The device is intended for use with bone graft and with supplemental fixation systems (such as anterior plating systems, or posterior screw systems) cleared for use in the spine.

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

| <div><span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span></div> |
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| <div><span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> |

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# 510(k) Summary Traditional 510k

as required by section 807.92(c).

## VERTA Corpectomy Cage K143490 Prepared 1/20/15

| Submitter: | Camber Spine Technologies<br>418 E Lancaster Ave.<br>Wayne, PA 19087 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person | Dan Pontecorvo<br>President<br>Phone: [phone], Fax: [phone]<br>Email: [e-mail] |
| Trade Name | VERTA Corpectomy Cage |
| Common Name | Spinal Vertebral Body Replacement Device |
| Device Class | Class II |
| Classification Name<br>and Number | Spinal intervertebral body fixation orthosis,<br>21 CFR 888.3060 |
| Classification Panel: | Orthopedic |
| Product Code | MQP |
| Reason for 510k | New Device |
| Predicate Device | NIKO Corpectomy Spacer (K 072465) |

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| Device Description | The VERTA Corpectomy Cage device is a vertebral body replacement<br>device used to provide structural stability in skeletally mature<br>individuals following Corpectomy or vertebrectomy. The VERTA<br>System is comprised of implants of various heights, to fit the needs of<br>individual patient anatomy. Geometrically, the implants are designed<br>as a load bearing frame with a hollow center which are applied to the<br>spine to provide long-term structural support throughout fusion and<br>to help enhance the fusion rate. Serrations on the superior and<br>inferior surfaces of the device are designed to grip the endplates of<br>the adjacent vertebrae to resist expulsion. The VERTA System<br>implants are made from PEEK radiolucent material with embedded<br>tantalum x-ray markers as specified in ASTM F2026 and ASTM F560,<br>respectively. |
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| Indications for Use | The VERTA Corpectomy Cage is a vertebral body replacement device<br>intended for use in the thoracolumbar spine (T1-L5) to replace a<br>collapsed, damaged, or unstable vertebral body due to tumor or<br>trauma (i.e., fracture). The device is intended for use with bone graft and<br>with supplemental fixation systems (such as anterior plating systems, or<br>posterior screw systems) cleared for use in the spine. |

| Materials: | The implant is manufactured from Solvay Zeniva ZA-500 implant grade Polyetheretherketone (PEEK) (per ASTM2026).<br>The accessories are manufactured from 17-4 Stainless Steel (per ASTM F899-11) |
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| Statement of<br>Technological<br>Comparison | VERTA Corpectomy Cage and its predicate device have the same<br>indications for use, similar design, technical characteristics, and test<br>results. Both devices are manufactured using materials with a long<br>history of use in orthopedic implants. |
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| Nonclinical Test<br>Summary | The following tests were performed to demonstrate that the VERTA Corpectomy Cage is<br>substantially equivalent to other predicate device.<br>Static Compression Test per ASTM F2077 Dynamic Compression Test per ASTM F2077 Static Torsion Test per ASTM F2077 Dynamic Torsion Test per ASTM F2077 Subsidence Test per ASTM F2267 Expulsion Test The results of these studies showed that the VERTA Cage met the acceptance criteria. |
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| Clinical Test<br>Summary | No clinical tests were performed. |

| Sterilization Information | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implants | The Implant will be shipped non-sterile and will be autoclaveable, validation testing of<br>the process was conducted (using the half-cycle method) to a Sterility Assurance Level<br>(SAL) of $10^-6$ per ISO 17665. |
| Instruments and<br>Case | The instrument and case will be shipped non-sterile and will be autoclaveable,<br>validation testing of the process was conducted (using the half-cycle method) to a<br>Sterility Assurance Level (SAL) of $10^-6$ per ISO 17665. |

| Conclusion | The VERTA Corpectomy Cage is substantially equivalent to its predicate device. This<br>conclusion is based upon the fact the VERTA Cage and its predicate device have the<br>same indications for use, have a similar design and technical characteristics, similar test<br>results, and any differences do not raise question of safety and effectiveness. |
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