INFILL INTERVERTEBRAL BODY FUSION DEVICE

K103729 · Pinnacle Spine Group, LLC · MAX · Apr 18, 2011 · Orthopedic

Device Facts

• Record ID: K103729
• Device Name: INFILL INTERVERTEBRAL BODY FUSION DEVICE
• Applicant: Pinnacle Spine Group, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Apr 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

InFill™ is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. InFill™ is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Device Story

InFill™ Intervertebral Body Fusion Device is a radiolucent spinal implant used to facilitate fusion in the lumbar spine. Manufactured from PEEK with tantalum markers, the device is implanted by a surgeon during spinal fusion procedures. It acts as a structural spacer to support the vertebral column while autogenous bone graft promotes fusion. Used in conjunction with supplemental internal spinal fixation systems, the device helps treat degenerative disc disease and spondylolisthesis. It is provided sterile for single use.

Clinical Evidence

Bench testing only. Performance data includes static/dynamic compression (ASTM F2077), static subsidence (ASTM F2267), and expulsion testing to demonstrate mechanical equivalence to predicate devices.

Technological Characteristics

Radiolucent PEEK implant with tantalum markers. Dimensions vary based on patient anatomy. Mechanical testing performed per ASTM F2077 (static/dynamic compression) and ASTM F2267 (static subsidence). Provided sterile for single use.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis at one or two contiguous lumbar levels (L2-S1). Requires six months of prior non-operative treatment. Must be used with autogenous bone graft and supplemental internal spinal 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

• NuVasive CoRoent System (K071795)
• Globus Medical Patriot Transcontinental LLIF Spacer (K093242)

Submission Summary (Full Text)

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Section 6

# 510(k) Summary

#### 6. 510(k) Summarv

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT: | Pinnacle Spine Group, LLC |
|---------------------------|--------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | February 21, 2011 |
| CONTACT PERSON: | Rebecca K Pine<br>1601 Elm Street, Suite 300<br>Dallas, TX 75201<br>Phone: [phone]<br>Fax: [phone] |
| TRADE NAME: | InFill™ Intervertebral Body Fusion Device |
| COMMON NAME: | Spinal Implant |
| CLASSIFICATION<br>NAME: | Intervertebral Body Fusion Device |
| DEVICE<br>CLASSIFICATION: | Class II |
| REGULATION<br>NUMBER | 888.3080 (product code:MAX) |
| PREDICATE DEVICES: | NuVasive CoRoent System, K071795<br>Globus Medical Patriot Transcontinental LLIF Spacer<br>K093242 |

#### Substantially Equivalent To:

The InFill™ intervertebral body fusion device is substantially equivalent in intended use, principal of operation and technological characteristics to the NuVasive CoRoent System and the Globus Medical Patriot Transcontinental LLIF Spacer.

### Description of the Device Subject to Premarket Notification:

The InFill™ intervertebral body fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient.

The InFill™ intervertebral body fusion device is provided sterile, for single use only.

## Indication for Use:

InFill™ is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. InFill™ is intended for use at either one level or two contiguous levels in the lumbar

APR 1 8 2011

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spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

## Technical Characteristics:

The InFill™ intervertebral body fusion device has similar physical and technical characteristics to the predicate devices.

# Performance Data:

All necessary performance testing, has been completed for the InFill™ intervertebral body fusion device including static/dynamic compression (ASTM F2077), static subsidence (ASTM F2267) and expulsion. to assure substantial equivalence to the predicate devices.

# Basis for Determination of Substantial Equivalence:

Upon reviewing the performance data provided in this submission and comparing intended use, design, materials, principle of operation and overall technological characteristics, the InFill™ intervertebral body fusion device is determined by Pinnacle Spine Group, LLC, to be substantially equivalent to existing legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Pinnacle Spine Group, LLC % Ms. Rebecca K. Pine 1601 Elm Street, Suite 300 Dallas, Texas 75201

APR 1 8 201

Re: K103729

Trade/Device Name: InFill" Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 12, 2011 Received: April 13, 2011

Dear Ms. Pine:

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 - Ms. Rebecca K. Pine

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.

lf 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,

AS vs. rh
fer

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

Enclosure

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5. Indications for Use Statement

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: InFill™ Intervertebral Body Fusion Device

Indications for Use:

InFill™ is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. InFill™ is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

| Prescription Use | X |
|--------------------------|---|
| (Per 21 CFR 801.109) | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) | |

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

| 510(k) Number | K103729 |
|---------------|---------|
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