CAMBER SPINE DIAGON OBLIQUE CAGE

K134038 · Camber Spine · MAX · Mar 20, 2014 · Orthopedic

Device Facts

• Record ID: K134038
• Device Name: CAMBER SPINE DIAGON OBLIQUE CAGE
• Applicant: Camber Spine
• Product Code: MAX · Orthopedic
• Decision Date: Mar 20, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Camber Spine Technologies Diagon Oblique Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Camber Spine Technologies Diagon Oblique Cage is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. Camber Spine Technologies Diagon Oblique Cage implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

The Diagon Oblique Cage is a hollow, textured intervertebral fusion device designed for the lumbar spine. It is implanted by a surgeon via an open transforaminal or posterior approach to facilitate fusion of adjacent bony surfaces. The device is hollow to allow bone growth through the cage. It is used in conjunction with autologous bone graft and supplemental fixation to stabilize the spine in patients with degenerative disc disease. The device is manufactured from radiolucent PEEK with embedded tantalum markers for radiographic visualization.

Clinical Evidence

No clinical data. Bench testing only, including static compression, static compression shear, subsidence, and static expulsion tests performed per ASTM F2077 and ASTM F2267.

Technological Characteristics

Material: Implant grade PEEK (ASTM F2026, Solvay Zeniva ZA-500) with tantalum x-ray markers (ASTM F560). Design: Hollow, textured, convex-sided cage. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). Includes patients with up to Grade I spondylolisthesis or retrolisthesis. Requires autologous bone graft and supplemental fixation. Contraindicated in patients without 6 months of prior non-operative treatment.

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

• Camber Spine Technologies TLS 5.0 Interbody Cage (K121254)

Submission Summary (Full Text)

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Special 510(k) Summary

mar 2 0 2014

as required by section 807.92(c).

# Camber Spine Technologies Diagon Oblique Cage K 134038

| Revised | March 20, 2014 |
|-----------------------|-----------------------------------------------------------------|
| Submitter: | Camber Spine Technologies |
| | 90 S. Newtown Street Rd., Suite #10 |
| | Newtown Square, PA 19073 |
| Contact Person | Dan Pontecorvo |
| | President |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Trade Name | Diagon Oblique Cage |
| Common Name | Oblique Cage |
| Device Class | Class II |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| and Number | 21 CFR 888.3080 |
| Classification Panel: | Orthopedic |
| Product Code | MAX |
| Predicate Devices | Camber Spine Technologies TLS 5.0 Interbody Cage (K121254) |
| Device Description | Camber Spine Technologies, Diagon Oblique Cage is a device |
| | for interbody fusion of the anterior column of the spine. These |
| | cages are hollow so that bone can grow through the device, |
| | fusing the adjacent bony surfaces. |
| | Camber Spine Technologies, Diagon Oblique Cage is a hollow |
| | device with texture on two opposing convex sides, and is |
| | offered in various lengths, widths, heights and shapes. Camber |
| | Spine designed the Camber Spine Technologies, Diagon |
| | Oblique Cage to be placed through a transforaminal or |
| | posterior approach and to address vertebrae in the |
| | lumbosacral region of the spine. |
| | The Camber Spine Technologies, Diagon Oblique Cage is made |
| | from Implant grade (PEEK) per ASTM2026 (Solvay Zeniva ZA- |
| | 500) which is a radiolucent material with embedded tantalum |
| | x-ray markers as specified in ASTM F560. |
| Indications for Use | The Camber Spine Technologies Diagon Oblique Cage is |
| | indicated for intervertebral body fusion procedures in |
| | skeletally mature patients with degenerative disc disease |
| | (DDD) of the lumbar spine at one or two contiguous levels from |
| | L2-S1. DDD is defined as discogenic pain with degeneration of |
| | the disc confirmed by history and radiographic studies. These |
| | DDD patients may also have up to Grade I spondylolisthesis or |
| | retrolisthesis at the involved level(s). Camber Spine |
| | Technologies Diagon Oblique Cage is to be used with |
| | autologous bone graft and implanted via an open |
| | transforaminal or posterior approach. |
| | Camber Spine Technologies Diagon Oblique Cage implants are |
| | to be used with supplemental fixation. Patients should have at |
| | least six (6) months of non-operative treatment prior to |
| | treatment with an intervertebral cage. |

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| Statement of<br>Technological<br>Comparison and<br>Fundamental Scientific<br>Technology | Camber Spine Diagon Oblique Cage and its predicate device<br>have the same indications for use, similar design, same<br>materials, technology principles of operation and test<br>results. |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

.

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.

.

| Nonclinical Test<br>Summary | The following tests were performed to demonstrate that the<br>Camber Spine Technologies Diagon Oblique Cage is<br>substantially equivalent to other predicate devices.<br>Static Compression Test per ASTM F2077 Static Compression Shear ASTM F2077 Subsidence Test per ASTM F2267 Static Expulsion Test The results of these studies showed that the Camber Spine<br>Technologies Diagon Oblique Cage met the acceptance criteria. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test Summary | n/a |

| Conclusion | Camber Spine Technologies Diagon Oblique Cage and its |
|------------|---------------------------------------------------------------|
| | predicate device have the same indications for use, similar |
| | design, and test results. Both devices are manufactured using |
| | materials with a long history of use in orthopaedic implants. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains the text 'Public Health Service' in a bold, sans-serif font. The text is arranged horizontally, with each word clearly legible. The overall appearance is clean and straightforward, suggesting a formal or official context.

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: K134038

Trade/Device Name: Camber Spine Technologies Diagon Oblique Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 19, 2014 Received: February 21, 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.fda.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/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 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. Wigqins

- 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) K134038

Device Name

Camber Spine Technologies Diagon Oblique Cage

#### Indications for Use (Describe)

The Camber Spine Technologies Diagon Oblique Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Camber Spine Technologies Diagon Oblique Cage is to be used with autologous bone graft and implanted via an open transforminal or posterior approach.

Camber Spine Technologies Diagon Oblique Cage implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

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

2 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)

## Anton E. Dmitriev, PhD

# Division of Orthopedic Devices

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