INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60

K133721 · Pinnacle Spine Group, LLC · MAX · Mar 31, 2014 · Orthopedic

Device Facts

• Record ID: K133721
• Device Name: INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60
• Applicant: Pinnacle Spine Group, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Mar 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device 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® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.

Device Story

Radiolucent spinal implants (InFill 41-TLIF, 43-TLIF, 44-TLIF, 60-ALIF) designed for intervertebral body fusion; manufactured from PEEK with tantalum markers. Implants feature central fenestration for bone graft support and surface teeth for fixation. Used by surgeons in clinical settings via anterior, lateral, or transforaminal approaches. Implants provide structural support to the disc space to facilitate fusion in patients with degenerative disc disease. Used in conjunction with supplemental internal spinal fixation systems. Provided sterile for single use.

Clinical Evidence

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

Technological Characteristics

Materials: PEEK OPTIMA, tantalum markers. Design: Box, oval, or banana-shaped with bullet nose; central fenestration for bone graft; surface teeth for bone-to-implant interface. Standards: ASTM F2077 (compression), ASTM F2267 (subsidence). Sterilization: Sterile, 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 at least six months of failed 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 Interbody Fusion Device (K103729, K121733, K124012)
• Novel TL Spinal Spacer System (K080699)
• Calix-A Lumbar Spinal Implant System (K131350)

Reference Devices

• Biomet Enclave (K081636)

Submission Summary (Full Text)

{0}------------------------------------------------

## MAR 3 1 2014

## 6. 510(k) Summary

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: | March 22, 2014 |
| CONTACT PERSON: | Rebecca K Pine<br>1601 Elm Street, Suite 1930<br>Dallas, TX 75201<br>Phone: [phone]<br>Fax: [phone] |
| TRADE NAME: | InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the<br>InFill® 60-ALIF |
| COMMON NAME: | Spinal Implant |
| CLASSIFICATION NAME: | Intervertebral Body Fusion Device |
| DEVICE CLASSIFICATION: | Class II |
| REGULATION NUMBER | 888.3080 (product code: MAX) |
| PREDICATE DEVICES: | InFill Interbody Fusion Device (K103729, K121733, K124012)<br>Novel TL Spinal Spacer System, (K080699)<br>Calix-A Lumbar Spinal Implant System (K131350) |

## Substantially Equivalent To:

The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF devices are substantially equivalent in intended use, principal of operation and technological characteristics to the InFill Interbody Fusion Device, Novel Spinal Spacer System and the Calix-A Lumbar Spinal Implant System.

## Description of the Device Subject to Premarket Notification:

The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF are radiolucent implantable devices manufactured from PEEK and tantalum (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient.

. The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF are provided sterile, for single use

{1}------------------------------------------------

only.

## Indication for Use:

InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device 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® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.

#### Technical Characteristics:

The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF have similar physical and technical characteristics to the predicate devices, as illustrated in the table below.

| Technical<br>Characteristics | In Fill®<br>intervertebral<br>body fusion<br>devices, (41-<br>TLIF Convex<br>Oblique, 43-<br>/44-TLIF<br>Contour<br>Oblique, 60-<br>ALIF) | In Fill®<br>intervertebral<br>body fusion<br>device<br>(K103729,<br>K121733,<br>K124012) | Novel TL<br>Spinal Spacer<br>System,<br>(K080699) | Calix-A<br>Lumbar<br>Spinal<br>Implant<br>System<br>(K131350) | Biomet<br>Enclave<br>(K081636) |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------|--------------------------------|
| Shape | Box-shaped,<br>bullet nose<br>Oval shape,<br>bullet nose<br>Banana-shaped,<br>bullet nosed | Box-shaped,<br>bullet nose | Banana-shaped,<br>bullet nosed | Oval shape,<br>bullet nose | Oval<br>shape,<br>bullet nose |
| Bone to implant<br>surface | Surface teeth | SAME | SAME | SAME | SAME |
| Bone graft<br>support feature | Central<br>fenestration | SAME | SAME | SAME | SAME |
| Primary<br>implant<br>material | PEEK OPTIMA<br>® | SAME | SAME | SAME | SAME |
| Surgical<br>Approach | Transforaminal<br>Anterior | Lateral<br>Transforaminal | Transforaminal | Anterior | Anterior |

Pinnacle Spine Group, LLC InFill® Product Family

{2}------------------------------------------------

## Performance Data:

All necessary performance testing, has been completed for the InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF devices 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® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF devices are determined by Pinnacle Spine Group, LLC, to be substantially equivalent to existing legally marketed devices.

{3}------------------------------------------------

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

March 31, 2014

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

Re: K133721

Trade/Device Name: Infill® Interbody Fusion Devices (Infill® 41-TLIF Convex Oblique, Infill® 43-TLIF Contour Oblique, Infill® 44-TLIF Contour Oblique, and the Infill® 60-ALIF)

Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: January 9, 2014 Received: January 10, 2014

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

{4}------------------------------------------------

#### 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.

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" (21 CFR 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/McdicalDevices/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.

# Ronald P. Jean -S for

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

Enclosure

{5}------------------------------------------------

## Indications for Use

510(k) Number (if known) K133721

Device Name InFill® Interbody Fusion Devices

#### Indications for Use (Describe)

InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DD) 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 lumbardevices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

球的方法: 大利亚 FOR FDA USE ONLY ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

## Anton E. Dmitriev, PhD

Division of Orthopedic Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."