INFILL OBLIQUE TLIF DEVICE

K124012 · Pinnacle Spine Group, LLC · MAX · Jun 4, 2013 · Orthopedic

Device Facts

• Record ID: K124012
• Device Name: INFILL OBLIQUE TLIF DEVICE
• Applicant: Pinnacle Spine Group, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Jun 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

InFill™ TLIF Oblique is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ TLIF Oblique is designed for use with autogenous bone graft to facilitate fusion. InFill™ TLIF Oblique 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™ TLIF Oblique 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™ TLIF Oblique is a radiolucent intervertebral body fusion device; manufactured from PEEK OPTIMA® with tantalum markers. Implant features box-shaped design with bullet nose, surface teeth for bone engagement, and central fenestration for bone graft support. Device is provided sterile for single-use. Intended for transforaminal lumbar interbody fusion (TLIF) procedures; implanted by surgeons in clinical settings. Device acts as a spacer to maintain disc height and facilitate fusion when used with autogenous bone graft and supplemental internal spinal fixation. Benefits include stabilization of the lumbar spine in patients with DDD and spondylolisthesis.

Clinical Evidence

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

Technological Characteristics

Materials: PEEK OPTIMA® and tantalum markers. Design: Box-shaped with bullet nose, surface teeth, and central fenestration. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Provided sterile. Standards: ASTM F2077 (compression), ASTM F2267 (subsidence).

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 at least 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

• InFill Intervertebral Body Spacer (K103729, K121733)
• Choice Spine ORIA Natura Spacer (K073669)
• Nuvasive CoRoent TLIF (K120918)

Submission Summary (Full Text)

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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: | May 7, 2013 | | |
| CONTACT PERSON: | Rebecca K Pine<br>1601 Elm Street, Suite 1930<br>Dallas, TX 75201<br>Phone: [phone]<br>Fax: [phone] | | |
| TRADE NAME: | InFill™ TLIF Oblique | | |
| 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: | InFill Intervertebral Body Spacer (K103729, K121733<br>Choice Spine ORIA Natura Spacer, (K073669)<br>Nuvasive CoRoent TLIF (K120918) | | |

### Substantially Equivalent To:

The InFill™ TLIF Oblique device is substantially equivalent in intended use, principal of operation and technological characteristics to the Choice Spine ORIA Natura Spacer and Nuvasive CoRoent TLIF devices.

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

The InFill™ TLIF Oblique 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™ TLIF Oblique is provided sterile, for single use only.

### Indication for Use:

InFill™ TLIF Oblique is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ TLIF Oblique is designed for use with autogenous bone graft to

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facilitate fusion. InFill™ TLIF Oblique 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™ TLIF Oblique 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™ TLIF Oblique has similar physical and technical characteristics to the predicate devices, as illustrated in the table below.

| Technical<br>Characteristics | InFill™ TLIF<br>Oblique | InFill™<br>intervertebral<br>body fusion<br>device<br>(K103729,<br>K121733) | Choice Spine<br>ORIA Natura<br>Spacer (K073669) | Nuvasive<br>CoRoent TLIF<br>(K120918) |
|-------------------------------|----------------------------|-----------------------------------------------------------------------------|-------------------------------------------------|---------------------------------------|
| Shape | Box-shaped, bullet<br>nose | SAME | SAME | SAME |
| Bone to implant<br>surface | Surface teeth | SAME | SAME | SAME |
| Bone graft<br>support feature | Central<br>fenestration | SAME | SAME | SAME |
| Primary implant<br>material | PEEK OPTIMA ® | SAME | SAME | SAME |
| Surgical<br>Approach | Transforaminal | Lateral | Posterior and<br>Transforaminal | Transforaminal |

# Performance Data:

All necessary performance testing, has been completed for the InFillTM TLIF Oblique 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 operall technological characteristics, the InFill™ TLIF Oblique device is determined by Pinnacle Spine Group, LLC, to be substantially equivalent to existing legally marketed devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized wings and body.

#### Public Health Service

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

June 4. 2013

Pinnacle Spine Group, LLC % Ms. Rebecca K. Pine 1601 Elm Street. Suite 1930 Dalias, Texas 75201

Re: K124012

Trade/Device Name: InFill™ TLIF Oblique Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 7, 2013 Received: May 9. 2013

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. Iisting 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

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### Page 2 - Ms. Rebecca K. Pine

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 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/Resourcesfor You/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.

For

Mark N. Melkerson

Sincerely yours,

Director Division of Orthopedic 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): ___K124012

Device Name: InFill™ TLIF Oblique Device

Indications for Use:

InFill™ TLIF Oblique is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ TLIF Oblique is designed for use with autogenous bone graft to facilitate fusion. InFill™ TLIF Oblique 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 nonoperative treatment. InFill™ TLIF Oblique is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

# (PLEASE DO NOT WRITE BELOW THIS LINE __ CONTINUE.ON ANOTHER PAGE IF NEEDED)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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