CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE

K121254 · Camber Spine Technologies · MAX · Jan 11, 2013 · Orthopedic

Device Facts

• Record ID: K121254
• Device Name: CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE
• Applicant: Camber Spine Technologies
• Product Code: MAX · Orthopedic
• Decision Date: Jan 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Camber Spine Technologies TLS 5.0 Interbody 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 TLS 5.0 Interbody Cage is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. Camber Spine Technologies TLS 5.0 Interbody 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

Hollow interbody fusion cage; manufactured from PEEK; textured on two opposing convex sides; available in various lengths, widths, heights, and shapes. Implanted via open transforaminal or posterior approach in the lumbosacral spine; requires autologous bone graft and supplemental fixation. Used by surgeons in clinical settings to facilitate intervertebral body fusion in patients with degenerative disc disease. Device provides structural support and a space for bone growth between adjacent vertebrae; promotes spinal stability and fusion.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by non-clinical bench testing, including static and dynamic compression (ASTM F2077), static and dynamic compression shear (ASTM F2077), subsidence (ASTM F2267), wear debris (ASTM F2077 and ASTM F1877), and static expulsion testing.

Technological Characteristics

Material: ASTM F2026 Solvay Zeniva ZA-500 implant-grade PEEK. Form factor: Hollow cage with textured convex surfaces. Sterilization: Non-sterile, autoclaveable (validated via half-cycle method to SAL 10^-6 per ISO 17665).

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1), including those with up to Grade I spondylolisthesis or retrolisthesis, who have failed at least 6 months of 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

• Corelink Foundation Cage (K073440)
• Stryker AVS PL (K093704)
• K2M Aleutian (K113138)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Camber Spine Technologies. The logo consists of a stylized letter "C" in a square on the left, followed by the words "Camber Spine Technologies" on the right. The words "Camber" and "Spine" are stacked on top of each other, with "Technologies" below.

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JAN 1 1 2013

## 510(k) Summary

as required by section 807.92(c).

### TLS 5.0 Interbody Cage

#### K121254

Camber Spine Technologies

401 Yankee Court

Newtown Square, PA 19073

Daniel A Pontecorvo

President

Phone: [phone]

Fax: [phone] ·

Email: [e-mail]

Submitted 1/7/13

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·

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| Submitter: | Camber Spine Technology<br>401 Yankee Court<br>Newtown Square, PA 19073 |
|----------------|-------------------------------------------------------------------------------------------|
| Contact Person | Daniel A Pontecorvo<br>President<br>Phone: [phone]<br>Email: [e-mail] |

| Trade Name | Camber Spine Technologies TLS 5.0 Interbody Cage |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | TLS 5.0 Interbody Cage |
| Device Class | Class II |
| Classification Name<br>and Number | Intervertebral Fusion Device With Bone Graft, Lumbar<br>21 CFR 888.3080 |
| Classification Panel: | Orthopedic |
| Product Code | MAX |
| Reason for 510k | New Device |
| Predicate Devices | Corelink Foundation Cage (K 073440), Stryker AVS PL (K093704) &<br>K2M Aleutian (K113138) |
| Device Description | Camber Spine Technologies, TLS 5.0 Interbody Cage is a device for<br>interbody fusion of the anterior column of the spine. These cages are<br>hollow so that bone can grow through the device, fusing the adjacent<br>bony surfaces.<br><br>Camber Spine Technologies, TLS 5.0 Interbody Cage is a hollow device<br>with texture on two opposing convex sides, and is offered in various<br>lengths, widths, heights and shapes. Camber Spine designed the<br>Camber Spine Technologies, TLS 5.0 Interbody Cage to be placed<br>through a transforaminal or posterior approach and to address<br>vertebrae in the lumbosacral region of the spine. |

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100 - 100 - 100

:

| | The Camber Spine Technologies TLS 5.0 Interbody Cage is indicated for |
|--------------|-----------------------------------------------------------------------------|
| Intended Use | 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 TLS 5.0 |
| | Interbody Cage is to be used with autologous bone graft and implanted via |
| | an open transforaminal or posterior approach. |
| | Camber Spine Technologies TLS 5.0 Interbody 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. |

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

| Statement of | Camber Spine Technologies TLS 5.0 Interbody Cage and its predicate devices have the same indications for use, similar design, and test results. |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological | Both devices are manufactured using materials with a long history of use |
| Comparison | in orthopaedic implants. |

:

·

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| Nonclinical Test<br>Summary | The following tests were performed to demonstrate that the Camber Spine<br>Technologies TLS 5.0 Interbody Cage is substantially equivalent to other predicate<br>devices.<br>Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear 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 Camber Spine Technologies TLS 5.0<br>Interbody Cage met the acceptance criteria. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test<br>Summary | No clinical tests were performed. |

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| 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 TLS 5.0 Interbody Cage is substantially equivalent to its predicate devices. This |
|------------|---------------------------------------------------------------------------------------|
| | conclusion is based upon the fact the Lumbar Cage and its predicate devices have the |
| | same indications for use, have a similar design, and similar test results. |

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: January 11, 2013

Camber Spine Technologies % Mr. Daniel A. Pontecorvo President 401 Yankee Court Newtown Square, Pennsylvania 19073

Re: K121254

Trade/Device Name: Camber Spine Technologies TLS 5.0 Interbody Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 26, 2012 Received: November 28, 2012

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

## Mark N. Melkerson

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

K121254

Device Name:

510(k) Number:

Camber Spine Technologies TLS 5.0 Interbody Cage

Indications:

The Camber Spine Technologies TLS 5.0 Interbody 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 TLS 5.0 Interbody Cage is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.

Camber Spine Technologies TLS 5.0 Interbody 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.

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)

# AND NO

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K121254