Amendia Interbody Fusion Devices

K151322 · Amendia, Inc. · MAX · Sep 10, 2015 · Orthopedic

Device Facts

• Record ID: K151322
• Device Name: Amendia Interbody Fusion Devices
• Applicant: Amendia, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Sep 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone and supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage. The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Device Story

Interbody fusion implants; provide structural stability and maintain disc space distraction; used in cervical (C3-C7) and lumbar (L2-S1) spinal fusion procedures. Implants feature hollow centers for autograft bone placement and surface ridges to grip vertebral endplates; prevent expulsion. Used in conjunction with supplemental spinal fixation instrumentation. Operated by surgeons in clinical/OR settings. Benefits patients by facilitating intervertebral body fusion in cases of degenerative disc disease.

Clinical Evidence

Bench testing only. Performance testing conducted per ASTM F2077 and ASTM F1877 to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Materials: Invibio PEEK-Optima LT1 or Solvay Zeniva ZA-500 PEEK (ASTM F2026), Tantalum markers (ASTM F560), Titanium alloy (Ti6Al4V ELI, ASTM F136). Form factor: Hollow cages with surface ridges. Non-sterile, single-use. No software or energy source.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the cervical spine (C3-C7) with radicular symptoms, or lumbar spine (L2-S1) with discogenic back pain (including up to Grade I spondylolisthesis). Requires autograft bone and supplemental fixation. Contraindicated for patients without prior non-operative treatment (6 weeks for cervical, 6 months for lumbar).

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

• Zeus Intervertebral Fusion Devices (K081614)
• NuVasive CoRoent System (K141665)
• Valeo C Spacer System, Valeo II C IBF Device (K142264)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing to the right, with flowing lines beneath them.

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

September 10, 2015

Amendia, Incorporated Ms. Chelsea Proffitt Regulatory Affairs Specialist 1755 West Oak Parkway Marietta, Georgia 30062

Re: K151322

Trade/Device Name: Amendia Interbody Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: August 7, 2015 Received: August 10, 2015

Dear Ms. Proffitt:

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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forth in the quality systems (OS) 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/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/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 yours,

# 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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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K151322

Page 1 of 1

510(k) Number (if known)

K151322

Device Name Amendia Interbody Fusion Devices

#### Indications for Use (Describe)

The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone and supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary Amendia Interbody Fusion Devices

| Submitter: | Amendia, Inc.<br>1755 W. Oak Parkway<br>Marietta, GA 30062 |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Chelsea Proffitt<br>Regulatory Affairs Specialist<br>770-575-5181 (W), 877-420-1213 (F)<br>[e-mail] (e-mail) |
| Date Prepared: | June 3, 2015 |
| Trade Name: | Amendia Interbody Fusion Devices |
| Common Name: | Intervertebral body fusion device |
| Device Product Code<br>and Classification: | MAX, 888.3080, Class II, Intervertebral Fusion Device with Bone<br>Graft, Lumbar |
| | ODP, 888.3080, Class II, Intervertebral Fusion Device with Bone<br>Graft, Cervical |
| Primary Predicate: | Zeus Intervertebral Fusion Devices (K081614) |
| Additional Predicates: | NuVasive CoRoent System (K141665)<br>Valeo C Spacer System, Valeo II C IBF Device (K142264) |

Purpose of Submission: This 510(k) is intended to gain clearance for modifications to the Zeus Intervertebral Fusion System, including addition of dimensions, and to add Titanium implant configurations in addition to PEEK, for the ALIF, PLIF, TLIF and Cervical implant groups.

## Device Description:

The Amendia Interbody Fusion Devices consist of multiple components comprised of nonsterile, single-use implants fabricated from Invibio PEEK-Optima® LT1 or Solvay Advanced Polymers Zeniva™ ZA-500 PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation.

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The Amendia Interbody Fusion Devices are comprised of implants designed to treat the cervical and lumbar spine. The implants are available in a range of sizes and shapes to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

#### Indications and Intended use:

The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone and supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

## Summary of Technological Characteristics:

The subject Amendia Interbody Fusion Devices are substantially equivalent to predicate devices cleared by FDA for commercial distribution in the United States. The Subject Device was shown to have the same technological characteristics as its predicate devices through comparison of characteristics including design, intended use, material composition, and function. Both the subject and predicate devices are interbody devices designed to contain graft material and facilitate fusion between two vertebral bodies in the cervical and lumbar region of the spine.

## Summary of Performance Testing:

The substantial equivalence of the Amendia Interbody Fusion Devices to the predicate is shown by similarity in intended use, indications for use, materials and performance. Engineering analysis shows performance that is substantially equivalent. Additional testing was conducted per ASTM F2077 and ASTM F1877, as results from these tests were used to demonstrate substantial equivalence.

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# Conclusion:

Based on the comparison to predicate devices and performance testing, the Amendia Interbody Fusion Devices have been shown to be substantially equivalent to legally marketed predicate devices.