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.

Device Description

The VERTA Corpectomy Cage device is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following Corpectomy or vertebrectomy. The VERTA System is comprised of implants of various heights, to fit the needs of individual patient anatomy. Geometrically, the implants are designed as a load bearing frame with a hollow center which are applied to the spine to provide long-term structural support throughout fusion and to help enhance the fusion rate. Serrations on the superior and inferior surfaces of the device are designed to grip the endplates of the adjacent vertebrae to resist expulsion. The VERTA System implants are made from PEEK radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.

AI/ML Overview

This document describes the VERTA Corpectomy Cage, a vertebral body replacement device, and its acceptance criteria as demonstrated by nonclinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the ASTM standards used for testing, indicating the device must meet or exceed the performance requirements specified in these standards for spinal implants. The document states that "The results of these studies showed that the VERTA Cage met the acceptance criteria."

Test Category	Specific Test	Acceptance Criteria (Implied by standard)	Reported Device Performance
Mechanical Properties	Static Compression	Per ASTM F2077	Met acceptance criteria
	Dynamic Compression	Per ASTM F2077	Met acceptance criteria
	Static Torsion	Per ASTM F2077	Met acceptance criteria
	Dynamic Torsion	Per ASTM F2077	Met acceptance criteria
Material Interaction	Subsidence Test	Per ASTM F2267	Met acceptance criteria
Device Stability	Expulsion Test	N/A (Standard not specified)	Met acceptance criteria
Sterilization	Autoclave Validation	Sterility Assurance Level (SAL) of $10^{-6}$ per ISO 17665	Met SAL $10^{-6}$

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each nonclinical test (Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, Subsidence, Expulsion). The data provenance is from nonclinical, laboratory testing performed specifically for the device's clearance. There is no mention of country of origin of data as it pertains to clinical studies; these are physical tests. All testing appears to be prospective in the sense that it was conducted specifically to support this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as there was no clinical study involving human patients or expert interpretation of clinical data for the primary performance evaluation. The "ground truth" for the nonclinical tests is established by the ASTM and ISO standards themselves, against which the device's physical performance is measured.

4. Adjudication Method for the Test Set

This section is not applicable as there were no clinical or image interpretation studies requiring expert adjudication. The tests conducted were physical mechanical and material property tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical medical implant (corpectomy cage), not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

For the nonclinical tests, the "ground truth" is established by adherence to recognized national and international standards for spinal implant testing (ASTM F2077, ASTM F2267, ISO 17665). The device's performance against these standards constitutes the "ground truth" for its mechanical and sterilization efficacy.

8. The Sample Size for the Training Set

This section is not applicable as the device is a physical medical implant. There is no "training set" in the context of an algorithm or AI.

9. How the Ground Truth for the Training Set was Established

This section is not applicable for the same reasons as #8.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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 Traditional 510k

as required by section 807.92(c).

VERTA Corpectomy Cage K143490 Prepared 1/20/15

Submitter:	Camber Spine Technologies418 E Lancaster Ave.Wayne, PA 19087
Contact Person	Dan PontecorvoPresidentPhone: 484-427-7060, Fax: (484) 318-8031Email: dpontecorvo@cambermedtech.com
Trade Name	VERTA Corpectomy Cage
Common Name	Spinal Vertebral Body Replacement Device
Device Class	Class II
Classification Nameand Number	Spinal intervertebral body fixation orthosis,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 replacementdevice used to provide structural stability in skeletally matureindividuals following Corpectomy or vertebrectomy. The VERTASystem is comprised of implants of various heights, to fit the needs ofindividual patient anatomy. Geometrically, the implants are designedas a load bearing frame with a hollow center which are applied to thespine to provide long-term structural support throughout fusion andto help enhance the fusion rate. Serrations on the superior andinferior surfaces of the device are designed to grip the endplates ofthe adjacent vertebrae to resist expulsion. The VERTA Systemimplants are made from PEEK radiolucent material with embeddedtantalum x-ray markers as specified in ASTM F2026 and ASTM F560,respectively.
Indications for Use	The VERTA Corpectomy Cage is a vertebral body replacement deviceintended for use in the thoracolumbar spine (T1-L5) to replace acollapsed, damaged, or unstable vertebral body due to tumor ortrauma (i.e., fracture). The device is intended for use with bone graft andwith supplemental fixation systems (such as anterior plating systems, orposterior screw systems) cleared for use in the spine.

Device Description

The VERTA Corpectomy Cage device is a vertebral body replacementdevice used to provide structural stability in skeletally matureindividuals following Corpectomy or vertebrectomy. The VERTASystem is comprised of implants of various heights, to fit the needs ofindividual patient anatomy. Geometrically, the implants are designedas a load bearing frame with a hollow center which are applied to thespine to provide long-term structural support throughout fusion andto help enhance the fusion rate. Serrations on the superior andinferior surfaces of the device are designed to grip the endplates ofthe adjacent vertebrae to resist expulsion. The VERTA Systemimplants are made from PEEK radiolucent material with embeddedtantalum x-ray markers as specified in ASTM F2026 and ASTM F560,respectively.

Indications for Use

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

Materials:	The implant is manufactured from Solvay Zeniva ZA-500 implant grade Polyetheretherketone (PEEK) (per ASTM2026).The accessories are manufactured from 17-4 Stainless Steel (per ASTM F899-11)
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Statement ofTechnologicalComparison	VERTA Corpectomy Cage and its predicate device have the sameindications for use, similar design, technical characteristics, and testresults. Both devices are manufactured using materials with a longhistory of use in orthopedic implants.
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Nonclinical TestSummary	The following tests were performed to demonstrate that the VERTA Corpectomy Cage issubstantially equivalent to other predicate device.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.
Clinical TestSummary	No clinical tests were performed.

Nonclinical TestSummary

The following tests were performed to demonstrate that the VERTA Corpectomy Cage issubstantially equivalent to other predicate device.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.

Clinical TestSummary

No clinical tests were performed.

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

Conclusion	The VERTA Corpectomy Cage is substantially equivalent to its predicate device. Thisconclusion is based upon the fact the VERTA Cage and its predicate device have thesame indications for use, have a similar design and technical characteristics, similar testresults, and any differences do not raise question of safety and effectiveness.
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Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
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.(b)
Classification. Class II.