ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD

K100037 · Advanced Vertebral Solutions, LLC · MAX · Sep 23, 2010 · Orthopedic

Device Facts

• Record ID: K100037
• Device Name: ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD
• Applicant: Advanced Vertebral Solutions, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Sep 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Advanced Vertebral Solutions IBF device, when used with autologous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Advanced Vertebral Solutions IBF device is to be implanted via a transforaminal approach. The device is to be used singly in the lumbosacral spine with supplemental posterior fixation.

Device Story

Hollow intervertebral body fusion device (IBFD) designed for transforaminal lumbar interbody fusion (TLIF). Implanted by surgeons in the lumbosacral spine to facilitate fusion of adjacent vertebral surfaces. Device features textured surfaces on opposing convex sides to promote bone growth through the cage when packed with autologous bone graft. Requires supplemental posterior fixation. Available in various lengths, widths, heights, and banana-shaped geometries. Provides structural support to the anterior column of the spine to alleviate discogenic back pain.

Clinical Evidence

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

Technological Characteristics

Materials: ASTM F2026 PEEK and ASTM F136 Titanium Alloy 6Al4V. Radiopaque markers: Tantalum or Ti alloy. Form factor: Banana-shaped cage with ridged surface. Energy source: None (mechanical). Sterilization: Non-sterile (supplied).

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade 1 spondylolisthesis or retrolisthesis, who have failed six 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

• ParamountTM Intervertebral Body Fusion Device (K072120)
• Patriot TM Intervertebral Body Fusion Device (K072970)

Submission Summary (Full Text)

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## 510(k) Summary

# 1< 160037 SEP 2 3 2010

(

### Advanced Vertebral Solutions, EXPRESS IBFD

.

| Submitter: | ADVANCED VERTEBRAL SOLUTIONS, LLC |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 124 S. Maple Street |
| | Ambler, PA 19002 |
| Contact Person | Mike Dugery |
| | President |
| | Phone: [phone] |
| | Email: [e-mail] |
| Date Prepared | September 21, 2010 |
| Device Class | Class II |
| Trade Name | Advanced Vertebral Solutions, EXPRESS IBFD |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| and Number | 21 CFR 888.3080 |
| Classification Panel: | Orthopedics |
| Product Code | MAX |
| Predicate Devices | ParamountTM Intervertebral Body Fusion Device (K072120) |
| | and Patriot TM Intervertebral Body Fusion Device (K072970) |
| Device Description | Advanced Vertebral Solutions Express IBFD AVS Express 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. |
| | Advanced Vertebral Solutions Express IBFD AVS Express is a |
| | hollow device with texture on two opposing convex sides, and |
| | is offered in various lengths, widths, heights and shapes. |
| | Advanced Vertebral Solutions designed the Advanced Vertebral |
| | Solutions |
| | Express IBFD AVS Express to be placed through a |
| | transforaminal approach and to address vertebrae in the |
| | lumbosacral region of the spine. |
| | |
| Intended Use | The Advanced Vertebral Solutions IBF device, when used with<br>autologous bone graft, is indicated for use in patients with<br>Degenerative Disc Disease (DDD) at one or two contiguous<br>levels from L2 to S1. These DDD patients may also have up to<br>Grade 1 spondylolisthesis or retrolisthesis at the involved<br>level(s). DDD is defined as discogenic back pain with<br>degeneration of the disc confirmed by history and radiographic<br>studies. These patients should be skeletally mature and have<br>had six months of non-operative treatment.<br>The Advanced Vertebral Solutions IBF device is to be<br>implanted via a transforaminal approach. The device is to be<br>used singly in the lumbosacral spine with supplemental<br>posterior fixation. |
| Materials: | The implant is manufactured from ASTM2026 implant grade<br>Polyetheretherketone (PEEK) and ASTM F136 implant grade<br>Titanium Alloy 6Al4V. |

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| Statement of<br>Technological<br>Comparison | The purpose of this submission is to obtain market clearance for the<br>proposed the Advanced Vertebral Solutions EXPRESS IBFD. The<br>Advanced Vertebral Solutions EXPRESS IBFD and its predicate<br>devices have the same indications for use, have a similar design, and<br>are made of the similar materials and chemical composition. |
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|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Summary of Technological Comparison | | | |
|-------------------------------------|------------------------------------|-----------------------------|-----------------------------|
| Characteristic | Advanced<br>Vertebral<br>Solutions | Globus<br>Patriot | IST<br>Paramount |
| Material | PEEK ZA 500 or Ti alloy | PEEK-OPTIMA® | PEEK-OPTIMA® |
| Radiopaque<br>Markers | Tantalum or Ti alloy | Tantalum | Tantalum |
| Shape | Five Banana shapes | Banana | Banana |
| Surgical Approach | TLIF | Direct Posterior or<br>TLIF | Direct Posterior or<br>TLIF |
| Adjunctive Fixation | Required | Required | Optional |
| Bone to Implant<br>Surface | Ridged | Ridged | Ridged |
| How Supplied | Non-Sterile | Non-Sterile | Non-Sterile |

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| Nonclinical Test<br>Summary | The following tests were performed to demonstrate that the<br>Advanced Vertebral Solutions EXPRESS IBFD is substantially<br>equivalent to other predicate 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 subject Advanced<br>Vertebral Solutions EXPRESS IBFD met the acceptance<br>criteria. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test Summary | No clinical tests were performed. |
| Conclusion | The Advanced Vertebral Solutions EXPRESS IBFD is<br>substantially equivalent to its predicate devices. This<br>conclusion is based upon the fact that this device is substantially<br>equivalent in terms of indications for use, technological<br>characteristics, materials, design and principles of operation. |

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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 consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Advanced Vertebral Solutions. LLC % Mr. Mike Dugery President 124 South Maple Street Ambler, Pennsylvania 19002

SEP 2 3 2010

Re: K100037

Trade/Device Name: Advanced Vertebral Solutions EXPRESS IBFD Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 02, 2010 Received: September 03, 2010

Dear Mr. Dugery:

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

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Page 2 - Mr. Mike Dugery

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

[signature]

Mark N. Melk Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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10003

2 3 2010

#### Indications for Use

K100037 510(k) Number:

Device Name:

Advanced Vertebral Solutions EXPRESS IBFD

Indications:

The Advanced Vertebral Solutions EXPRESS IBFD, when used with autologous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from 1.2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The Advanced Vertebral Solutions EXPRESS IBFD is to be implanted via a transforaminal approach. The device is to be used singly in the lumbosacral spine with supplemental posterior fixation.

Prescription Use X

AND/OR

Over-the-counter

(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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K100037 510(k) Number_