InFill Interbody Fusion Devices

K151184 · Pinnacle Spine Group, LLC · MAX · Jul 14, 2015 · Orthopedic

Device Facts

• Record ID: K151184
• Device Name: InFill Interbody Fusion Devices
• Applicant: Pinnacle Spine Group, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Jul 14, 2015
• 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

InFill® Interbody Fusion Device is a radiolucent spinal implant used to facilitate fusion in lumbar spine surgery. Device is manufactured from PEEK OPTIMA LT1® with tantalum markers for radiographic visibility. Implant is available in various sizes and shapes (oval, bullet-nose) to accommodate patient anatomy. Used by surgeons in open or minimally invasive approaches (anterior, lateral, transforaminal). Device is implanted into the intervertebral space; filled with autogenous bone graft to promote fusion; requires supplemental internal spinal fixation. Provides structural support to the disc space; maintains disc height; facilitates long-term spinal stabilization. Intended for single-use; provided sterile.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by Finite Element Analysis (FEA) comparing the new device sizes to the existing product family to ensure mechanical integrity.

Technological Characteristics

Radiolucent intervertebral body fusion device. Materials: PEEK OPTIMA LT1® and tantalum (marker). Design: Oval-shaped with bullet nose; surface teeth for bone-to-implant interface; central fenestration for bone graft. Dimensions: Lengths 25-28mm, Widths 32-39mm, Heights 8-18mm. Sterile, single-use. Mechanical performance validated via FEA.

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 (K133721)
• ALIF STS Interbody Fusion Device (K112316)
• Interform Interbody Cage System (K131082)

Submission Summary (Full Text)

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Image /page/0/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 emblem featuring a stylized image of three human profiles facing to the right, stacked on top of each other.

July 14, 2015

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

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

Re: K151184

Trade/Device Name: Infill® Interbody Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 18, 2015 Received: May 19, 2015

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Rebecca 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Mark N. Melkerson -S

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

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Indications for Use</b> | |
| | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
| 510(k) Number (if known) | K151184 |
| 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.<br>InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody<br>fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the<br>treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of<br>discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to<br>be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is<br>intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar<br>spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches<br>include anterior, lateral and transforaminal. |
| Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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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: | July 8, 2015 |
| CONTACT PERSON: | Rebecca K Pine<br>1601 Elm Street, Suite 300<br>Dallas, TX 75201<br>Phone: [phone]<br>Fax: [phone] |
| TRADE NAME: | InFill® Interbody Fusion Devices |
| COMMON NAME: | Spinal Implant |
| CLASSIFICATION NAME: | Intervertebral Body Fusion Device |
| DEVICE CLASSIFICATION: | Class II, per 21 CFR 888.3080 |
| PRODUCT CODE | MAX |
| PREDICATE DEVICES: | (primary) InFill® Interbody Fusion Device (K133721)<br>ALIF STS Interbody Fusion Device (K112316)<br>Interform Interbody Cage System (K131082) |

#### Substantially Equivalent To:

The modified InFill® Interbody Fusion Device is substantially equivalent in intended use, principal of operation and technological characteristics to the InFill® Interbody Fusion Device cleared under premarket notification K133721 and the ALIF ST Interbody Fusion Device (K112316) and Interform Interbody Cage System (K131082).

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

The InFill® interbody 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® interbody fusion device is provided sterile, for single use 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

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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 modified InFill® intervertebral body fusion device has similar physical and technical characteristics to the predicate device. An additional length (26mm) has been added to the product family.

| Technical<br>Characteristics | InFill® interbody<br>fusion devices,<br>(60-ALIF) | InFill® interbody<br>fusion device (60-<br>ALIF)<br>(K133721) | ALIF STS<br>Interbody Fusion<br>Device<br>(K112316) | Interform<br>Interbody Cage<br>System<br>(K131082) |
|-------------------------------|---------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------|
| Shape | Oval-shaped, bullet<br>nose | Oval-shaped, bullet<br>nose | Oval-shaped | Oval-shaped, bullet<br>nose |
| Bone to implant<br>surface | Surface teeth | Surface teeth | Surface roughness | Surface teeth |
| Bone graft<br>support feature | SAME | Central<br>fenestration | Central<br>fenestration | Central<br>fenestration |
| Primary implant<br>material | PEEK OPTIMA<br>LT1 ® | PEEK OPTIMA<br>LT1 ® | Titanium | PEEK |
| Surgical<br>Approach | SAME | Anterior | Anterior | ALIF |
| Lengths (mm) | 25, 26, 28 | 25, 28 | "small"<br>"medium"<br>"large" | 24, 28, 30 |
| Widths (mm) | 32, 36, 39 | 36, 39 | "small"<br>"medium"<br>"large" | 30, 36, 39 |
| Heights (mm) | 8-18 | 10-18 | 8-17 | 10-20 |

# Performance Data:

An FEA (Finite Element Analysis) was performed to assess the introduction of the new InFill device sizes into the existing product family. The worst case construct was identified and characterized. The results of the analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new device sizes to the predicate device. The modified InFill® intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions.

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### Basis for Determination of Substantial Equivalence:

The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The modified InFill® interbody fusion device is found to have a safety and effectiveness profile that is similar to the predicate device and is determined by Pinnacle Spine Group LLC, to be substantially equivalent to the predicate devices.