CAMBER SPINE COVERIS CERVICAL CAGE

K133529 · Camber Spine · ODP · Mar 20, 2014 · Orthopedic

Device Facts

• Record ID: K133529
• Device Name: CAMBER SPINE COVERIS CERVICAL CAGE
• Applicant: Camber Spine
• Product Code: ODP · Orthopedic
• Decision Date: Mar 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a cervical intervertebral fusion device, the Coveris Cage is indicated for use at one level in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems (such as anterior cervical plating systems, or posterior systems) cleared for use in the cervical spine.

Device Story

Camber Spine Coveris Cage is an intervertebral body fusion device designed to maintain disc space distraction in the cervical spine. The device features a hollow center for autogenous bone graft placement and superior/inferior surface ridges to grip endplates and prevent expulsion. It is implanted by a surgeon during spinal fusion procedures. The device acts as a structural spacer to facilitate fusion between vertebral bodies. It is used in conjunction with supplemental spinal fixation instrumentation (e.g., anterior cervical plating or posterior systems). The device is provided non-sterile and requires autoclave sterilization by the user.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by bench testing including static and dynamic compression, shear, and torsion per ASTM F2077, subsidence testing per ASTM F2267, wear debris analysis per ASTM F2077/F1877, and static expulsion testing.

Technological Characteristics

Constructed from ASTM F2026 implant-grade PEEK (Solvay Zeniva ZA-500) with embedded tantalum x-ray markers (ASTM F560). Features hollow center for graft and surface ridges for fixation. Non-sterile, autoclavable. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring one-level cervical intervertebral fusion (C3-C7) for degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis, following six weeks of failed non-operative treatment. DDD defined as discogenic neck pain confirmed by history and radiography. Requires use with autogenous bone graft and supplemental fixation.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Corelink Foundation Cage (K073440)
• Nexxt Honour Spacer (K120345)
• Spinal Elements Crystal (K073351)

Submission Summary (Full Text)

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# MAR 2 0 2014

K133529

Page 1 of 3

## Traditional 510(k) Summary

as required by section 807.92(c).

## Camber Spine Technologies Coveris Cage K 133529

| Revised | March 20, 2014 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Camber Spine Technologies<br>90 S. Newtown Street Rd., Suite #10<br>Newtown Square, PA 19073 |
| Contact Person | Dan Pontecorvo<br>President<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Camber Spine Coveris Cage |
| Common Name | Intervertebral Body Fusion Device |
| Device Class | Class II |
| Classification Name<br>and Number | Intervertebral fusion device with bone graft, cervical<br>21 CFR 888.3080 |
| Classification Panel: | Orthopedic |
| Product Code | ODP |
| Reason for 510k | New Device |
| Predicate Devices | Corelink Foundation Cage (K 073440), Nexxt Honour Spacer<br>(K120345) & Spinal Elements Crystal (K073351) |
| Device Description | The Camber Spine Coveris Cage series of intervertebral body fusion<br>devices are used to maintain disc space distraction in skeletally<br>mature adults requiring intervertebral body fusion. They are<br>designed to be used in conjunction with supplemental spinal fixation<br>instrumentation. |
| | The series is comprised of cages of various fixed heights and shapes<br>for placement in the cervical spine. Each cage has a hollow center to<br>allow placement of graft material inside of the cage. Ridges on the<br>superior and inferior surfaces of the device help to grip the endplates<br>and prevent expulsion.<br>The Coveris Cage of intervertebral body fusion devices are made<br>from the PEEK radiolucent material with embedded tantalum x-ray<br>markers as specified in ASTM F2026 and ASTM F560, respectively. |
| Implants | The Implant will be shipped non-sterile and will be autoclaveable,<br>validation testing of the process was conducted (using the half-cycle<br>method) to a Sterility Assurance Level (SAL) of 10-6 per ISO 17665. |

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| Intended Use | When used as a cervical intervertebral fusion device, the Coveris<br>Cage is indicated for use at one level in the cervical spine, from C3-<br>C7, in skeletally mature patients who have had six weeks of non-<br>operative treatment for the treatment of degenerative disc disease<br>(DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck<br>pain of discogenic origin with degeneration of the disc confirmed by<br>history and radiographic studies. The device is intended for use with<br>autogenous bone graft and with supplemental fixation systems (such<br>as anterior cervical plating systems, or posterior systems) cleared for<br>use in the cervical spine. |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Materials: | The implant is manufactured from ASTM2026 Solvay Zeniva<br>ZA-500 implant grade Polyetheretherketone (PEEK) |
|------------|-------------------------------------------------------------------------------------------------------------|
|------------|-------------------------------------------------------------------------------------------------------------|

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#### K133529

T

T

| Statement of<br>Technological<br>Comparison | Camber Spine Coveris Cage and its predicate devices have the same<br>indications for use, similar design, and test results. Both devices are<br>manufactured using materials with a long history of use in orthopaedic<br>implants. |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Nonclinical Test<br>Summary | The following tests were performed to demonstrate that the Camber Spine Coveris<br>Cage is substantially equivalent to other predicate devices.<br>Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear ASTM F2077 Static and Dynamic Torsional ASTM F2077 Subsidence Test per ASTM F2267 Wear Debris ASTM F2077 and ASTM F1877 Static Expulsion Test The results of these studies showed that the Coveris Cage met the acceptance criteria. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test<br>Summary | No clinical tests were performed. |

| Conclusion | |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Camber Spine Coveris Cage is substantially equivalent to its predicate devices. This conclusion is based upon the fact the Coveris Cage and its predicate devices have the same indications for use, have a similar design and technical characteristics, similar test results, and any differences do not raise question of safety and effectiveness. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird-like figure. The logo is black and white.

Public Health Service

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

March 20, 2014

Camber Spine Technologies Mr. Daniel Pontecorvo President & CEO 90 South Newtown Street Road, Suite 10 Newtown Square, Pennsylvania 19073

Re: K133529

Trade/Device Name: Coveris Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 10, 2014 Received: February 18, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Daniel 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.lda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

### Lori A. Wiqqins

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: K133529

Device Name: Coveris Cage

Indications for Use:

When used as a cervical intervertebral fusion device, the Coveris devices are indicated for use at one level in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation (such as anterior cervical plating systems, or posterior systems) systems cleared for use in the cervical spine.

AND/OR Over-the-counter _____________________________________________________________________________________________________________________________________________________________ Prescription Use X (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Anton E. Dmitriev, PhD

Division of Orthopedic Devices