ALTA Anterior Cervical Interbody Spacer

K173324 · Astura Medical · ODP · Feb 27, 2018 · Orthopedic

Device Facts

• Record ID: K173324
• Device Name: ALTA Anterior Cervical Interbody Spacer
• Applicant: Astura Medical
• Product Code: ODP · Orthopedic
• Decision Date: Feb 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ALTA Anterior Cervical Interbody Spacer is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ALTA Anterior Cervical Interbody Spacer 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

ALTA Anterior Cervical Interbody Spacer; implant for cervical column stabilization. Trapezoidal footprint; multiple sizes; PEEK-OPTIMA LT120HA material. Features unidirectional teeth on superior/inferior surfaces to prevent migration; graft windows for bony integration; integrated X-ray markers for visualization. Used by surgeons in clinical settings for anterior cervical interbody fusion. Provides structural support during spinal fusion; facilitates bony integration via bone graft. Benefits patient by stabilizing cervical spine segments to address degeneration/instability.

Clinical Evidence

No clinical studies were performed. Substantial equivalence supported by non-clinical bench testing including static and dynamic compression (ASTM F2077), static and dynamic torsion (ASTM F2077), and subsidence (ASTM F2267).

Technological Characteristics

Materials: PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced), Tantalum (ASTM F560). Design: Trapezoidal interbody spacer with unidirectional teeth and graft windows. Energy source: None (mechanical implant). Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability (C2-T1) confirmed by imaging, resulting in radiculopathy, myelopathy, and/or pain. Requires supplemental fixation and use with autogenous/allogeneic 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

• Astura Medical ALTA Anterior Cervical Interbody Spacer (K160154)
• SpineFrontier Incorporated, Arena-C HA PEEK Cervical Intervertebral Body Fusion Device (K142026)
• NuVasive® CoRoent® Small Interbody System (K163491)

Submission Summary (Full Text)

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February 27, 2018

Astura Medical Mr. Thomas Purcell Vice President 3186 Lionshead Ave, Suite 100 Carlsbad, California 92010

Re: K173324

Trade/Device Name: ALTA Anterior Cervical Interbody Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 10, 2017 Received: December 15, 2017

Dear Mr. Purcell:

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 forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

# Katherine D. Kavlock -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) K173324

#### Device Name

ALTA Anterior Cervical Interbody Spacer

#### Indications for Use (Describe)

The ALTA Anterior Cervical Interbody Spacer is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ALTA Anterior Cervical Interbody Spacer 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="text-decoration: underline;"><b>☑</b></span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary: ALTA ANTERIOR CERVICAL INTERBODY SPACER

## PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced)

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

| Date Prepared | January 31st 2018 |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Astura Medical |
| | 3186 Lionshead Ave, Suite 100 |
| | Carlsbad, CA 92010 |
| | Phone: [phone] |
| Contact | Thomas Purcell |
| | 3186 Lionshead Ave, Suite 100 |
| | Carlsbad, CA 92010 |
| | Phone: [phone] |
| | Email: [e-mail] |
| Trade Name | ALTA Anterior Cervical Interbody Spacer |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral Body Fusion Device With Bone Graft, Cervical |
| Class | II |
| Product Code | ODP |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate Device | Astura Medical ALTA Anterior Cervical Interbody Spacer (K160154) |
| Additional Predicate<br>Device(s) | SpineFrontier Incorporated, Arena-C HA PEEK Cervical Intervertebral Body<br>Fusion Device (K142026), NuVasive® CoRoent® Small Interbody System<br>(K163491) |
| Device Description | The ALTA Anterior Cervical Interbody Spacer was developed as implants<br>for the stabilization of the cervical column. The devices have trapezoidal<br>footprints and multiple sizes to accommodate patient anatomy. This<br>device is offered in PEEK OPTIMA LT120HA. The PEEK OPTIMA LT120HA<br>implants have unidirectional teeth on both of their inferior and superior<br>surfaces to prevent migration/expulsion, and graft windows which help<br>facilitate bony integration. X-ray markers are integrated for visualization<br>of the implants during and after surgery. The titanium implants have<br>roughened superior and inferior surfaces to prevent migration of the<br>spacer post implantation. |
| Materials | PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) – MAF 2227 (added<br>material)<br>Tantalum per ASTM F560 |
| Substantial Equivalence<br>Claimed to Predicate<br>Devices | The PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) ALTA Anterior<br>Cervical Interbody Spacer are substantially equivalent to the predicate<br>devices in terms of intended use, design, material, and mechanical safety<br>and performances. |
| Indications for Use | The ALTA Anterior Cervical Interbody Spacer is indicated for<br>intervertebral body fusion of the spine in skeletally mature patients. The<br>ALTA Anterior Cervical Interbody Spacer is intended for use for anterior<br>cervical interbody fusion in patients with cervical disc degeneration<br>and/or cervical spinal instability, as confirmed by imaging studies<br>(radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or<br>pain at multiple contiguous levels from C2 - T1. The System is intended to<br>be used with supplemental fixation. The System is designed for use with<br>autogenous and/or allogeneic bone graft comprised of cancellous and/or<br>corticocancellous bone graft to facilitate fusion. |
| Non-clinical Test<br>Summary | The following analyses were conducted:<br>• Static and dynamic compression per ASTM F2077<br>• Static and dynamic torsion per ASTM F2077<br>• Subsidence per ASTM F2267<br>The results of these evaluations indicate that the PEEK-OPTIMA LT120HA<br>(PEEK-OPTIMA HA Enhanced) ALTA Anterior Cervical Interbody Spacer is<br>equivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-Clinical<br>and Clinical | Astura Medical considers the PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA<br>Enhanced) ALTA Anterior Cervical Interbody Spacer to be equivalent to<br>the predicate devices listed above. This conclusion is based upon the<br>devices' similarities in principles of operation, technology, materials and<br>indications for use. |

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