Atlas Spine Expandable Cervical Interbody System

K180675 · Atlas Spine, Inc. · ODP · Jun 13, 2018 · Orthopedic

Device Facts

• Record ID: K180675
• Device Name: Atlas Spine Expandable Cervical Interbody System
• Applicant: Atlas Spine, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Jun 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atlas Spine Expandable Cervical Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Expandable Cervical Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Device Story

Expandable cervical interbody fusion device; rectangular shape; height-adjustable; features bone graft cavities on superior/inferior surfaces; textured bone-contacting surfaces to prevent migration/expulsion; posterior opening for post-expansion bone graft delivery. Used by surgeons in clinical settings for anterior cervical interbody fusion. Implanted to facilitate fusion between adjacent vertebral bodies in patients with cervical disc degeneration or instability. Provides structural support to the spine; promotes bone fusion via autogenous/allogeneic graft. Delivered pre-assembled in unexpanded state.

Clinical Evidence

No clinical data. Bench testing only. Mechanical evaluation performed per ASTM F2077 and ASTM F2267, including static and dynamic testing for axial compression, shear, torsion, expulsion, and subsidence.

Technological Characteristics

Materials: Ti6Al4V (ASTM F136) and PEEK Optima LT1. Design: Rectangular, height-expandable interbody spacer. Features textured surfaces and bone graft cavities. Sterilization: Not specified. Connectivity: N/A. Software: N/A.

Indications for Use

Indicated for skeletally mature patients requiring anterior cervical interbody fusion for cervical disc degeneration and/or cervical spinal instability (confirmed by imaging) resulting in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. Must be used with supplemental fixation and bone graft.

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 Small Interbody System (K163491)
• Orthofix CONSTRUX™ MINI Peek Ti Spacer System (K121649)
• Southern Spine C-Fuse PEEK Cervical Fusion System (K130948)
• Atlas Spine Expandable Interbody System (K162918)

Submission Summary (Full Text)

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June 14, 2018

Atlas Spine, Inc. % Ms. Meredith May VP, Empirical Consulting, LLC Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K180675

Trade/Device Name: Atlas Spine Expandable Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 30, 2018 Received: May 30, 2018

Dear Ms. May:

This letter corrects our substantially equivalent letter of June 13, 2018.

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 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

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manufacturing practice requirements as set 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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Brent Showalter -S

for 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

510(k) Number (if known) K180675

Device Name

Atlas Spine Expandable Cervical Interbody System

#### Indications for Use (Describe)

The Atlas Spine Expandable Cervical Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Expandable Cervical Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Type of Use (Select one or both, as applicable)

| <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
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| <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

| Applicant/Sponsor: | Atlas Spine, Inc.<br>1555 Jupiter Park Drive, Suite 4<br>Jupiter, FL, 33458<br>[phone] |
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| Contact Person: | Meredith May<br>Empirical Consulting, LLC<br>4628 Northpark Drive<br>Colorado Springs, CO 80918<br>[phone] |
| Proposed Trade Name: | Atlas Spine Expandable Cervical Interbody System |
| Common Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Cervical<br>(21 CFR 888.3080) |
| Device Class: | Orthopedics panel Class II device |
| Device Product Code: | ODP |
| Predicate Devices:<br>Primary:<br>Additional:<br>Additional:<br>Additional: | NuVasive CoRoent Small Interbody System (K163491)<br>Orthofix CONSTRUX™ MINI Peek Ti Spacer System (K121649)<br>Southern Spine C-Fuse PEEK Cervical Fusion System (K130948)<br>Atlas Spine Expandable Interbody System (K162918) |

# Device Description:

The Atlas Spine Expandable Cervical Interbody System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implants incorporate a textured bone contacting surface to resist migration/expulsion of the implant post operatively. Additionally, the implant incorporates an opening posteriorly to allow the addition of bone graft post expansion.

The implants components are manufactured from implantable grade Ti6AI4V per ASTM F136 alloy and Peek Optima LT1 delivered in the pre-assembled, unexpanded state.

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## Indications for Use:

The Atlas Spine Expandable Cervical Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Expandable Cervical System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myclopathy, and/or pain at mulitple contiquous levels from C2 - T1. This system is intended to be used with supplemental fixation. The System is designed for use with autogenous and/ or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

# Substantial Equivalence

The Atlas Spine Expandable Cervical Interbody System has the same intended use, indications for use and similar manufacturing materials as the predicate device(s). The range of sizes of the Atlas Spine Expandable Interbody System is similar to the predicate device(s).

## Non-Clinical Testing

The Atlas Spine Expandable Cervical Interbody System was evaluated as recommended in FDA's Guidance for Industry and FDA Staff: Class II Special controls guidance document: Intervertebral body Fusion Device, dated June 12, 2007.

Bench testing was performed and consisted of the following test methods per ASTM F2077 and ASTM F2267:

- . Static testing in a load to failure mode in axial compression,
- . Static testing in a load to failure mode in shear,
- Static testing in a load to failure mode in torsion, ●
- Static testing in expulsion, ●
- Static testing in subsidence, ●
- o Dynamic axial compression testing to estimate the maximum run out load
- Dynamic compression shear testing to estimate the maximum run out load ●
- Dynamic torsion testing to estimate the maximum run out load ●

Test results demonstrated that the Atlas Spine Expandable Cervical Interbody System is found to be substantially equivalent to the predicate

### Clinical Performance Data Summary

No clinical testing was required.

### Conclusion

Based upon similarities in design, materials, intended use, indications for use and the results of mechanical testing, the Atlas Spine Expandable Cervical Interbody System is substantially equivalent to the predicate devices.