Alta ACDF System

K152622 · Biomet Spine · OVE · Jul 8, 2016 · Orthopedic

Device Facts

• Record ID: K152622
• Device Name: Alta ACDF System
• Applicant: Biomet Spine
• Product Code: OVE · Orthopedic
• Decision Date: Jul 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K152622 · Jul 8, 2016	Alta ACDF System	Biomet Spine	Published retrospective clinical literature	The sponsor conducted a retrospective evaluation of clinical literature to demonstrate that the use of allograft (cancellous and/or corticocancellous bone graft) in anterior cervical interbody fusion is safe and effective, supporting the expanded indications for the device.	Retrospective clinical data; Literature review; Allograft; Cervical fusion

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective evaluation of clinical literature; Retrospective literature review	Patients undergoing anterior cervical interbody fusion	Not applicable for this study	Safety and efficacy of allograft (cancellous and/or corticocancellous bone graft) in anterior cervical interbody fusion

Indications for Use

The Alta ACDF System is a stand-alone cervical fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Alta ACDF System is to be filled with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material, and is to be used with titanium alloy screws which accompany the implant.

Device Story

Alta ACDF System is a stand-alone cervical intervertebral body fusion device. Device consists of PEEK-OPTIMA spacer with hollow center for bone graft, Tantalum markers, and titanium alloy (Ti-6AI-4V ELI) screws for fixation. Spacer surfaces feature transverse slots/grooves for stability. Used by surgeons in clinical settings for cervical fusion. Device provides structural support and stabilization to the intervertebral space while facilitating fusion via autogenous or allogeneic bone graft. System is provided in various sizes to accommodate patient anatomy. No software or electrical components.

Clinical Evidence

No new clinical or bench testing was performed. Substantial equivalence is supported by a retrospective evaluation of published clinical literature for similar cervical interbody fusion devices, demonstrating that the use of allograft bone graft poses no new risks to patients.

Technological Characteristics

Materials: PEEK-OPTIMA, Tantalum, and Titanium alloy (Ti-6AI-4V ELI). Design: Hollowed central area for bone graft; transverse slots/grooves on superior/inferior surfaces for fixation. Form factor: Intervertebral spacer with integrated screw fixation. No software or electrical components.

Indications for Use

Indicated for skeletally mature patients with single-level degenerative disc disease (DDD) of the cervical spine (C3-T1) who have failed at least six weeks of non-operative treatment.

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

• Solitaire®-C Cervical Spacer System (K151064)
• C-Thru™ Anterior Spinal System (K151064)
• Breckenridge® Small Intervertebral Body Fusion System (K151064)
• Alta ACDF System (K112388)

Submission Summary (Full Text)

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

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.

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

July 8, 2016

Biomet Spine Ms. Alexandra Beck Regulatory Affairs Specialist 310 Interlocken Parkway, Suite 120 Broomfield, Colorado 80021

Re: K152622

Trade/Device Name: Alta ACDF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: June 3, 2016 Received: June 16, 2016

Dear Ms. Beck:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

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/ResourcesforYou/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 yours,

# Mark N. Melkerson -S

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

Enclosure

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

# Indications for Use

510(k) Number (if known)

K152622

Device Name Alta ACDF System

#### Indications for Use (Describe)

The Alta ACDF System is a stand-alone cervical fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Alta ACDF System is to be filled with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material, and is to be used with titanium alloy screws which accompany the implant.

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

| <div> <span> <span style="font-size: 16px;">☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </div> |
|-------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </div> |

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 [e-mail]

"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."

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

Image /page/3/Picture/0 description: The image shows the logo for BIOMET Spine. The word "BIOMET" is in large, bold, sans-serif letters. Below "BIOMET" is the word "SPINE" in smaller, sans-serif letters. The logo is in a dark gray color against a white background.

# 510(k) Summary

This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR § 807.92.

| Preparation Date: | 11September2015 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Spine<br>310 Interlocken Parkway, Suite 120<br>Broomfield, CO 80021 |
| Contact Person: | Alexandra Beck<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Trade name: | Alta ACDF System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name<br>(Product Code): | Intervertebral Fusion Device with Integrated Fixation, Cervical (OVE)<br>Class II per 21 CFR § 888.3080 |
| Device Panel: | Orthopedic |
| Primary Predicate: | Solitaire®-C Cervical Spacer System, C-Thru™ Anterior Spinal<br>System, and Breckenridge® Small Intervertebral Body Fusion System<br>(K151064) |
| Additional Predicate: | Alta ACDF System (K112388) |

#### Device Description:

The cervical intervertebral body PEEK spacers have a hollowed cut-out central area to accommodate autogenous and/or allogeneic bone graft and the upper and lower surfaces have a series of transverse slots or grooves to improve stability and fixation once the device is inserted. The implants in this system are made of PEEK-OPTIMA®, Tantalum, and Titanium alloy (Ti-6AI-4V ELI). The spacer body, plates and screws are available in a variety of sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy.

The Alta ACDF System is intended for stand-alone use in cervical intervertebral body fusion and must be used with the titanium alloy screws which accompany the implant.

This Traditional 510(k) is being submitted to seek clearance for the addition of allograft (cancellous and/or corticocancellous bone graft) indications to the Alta ACDF System.

#### Indications for Use:

The Alta ACDF System is a stand-alone cervical fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Alta ACDF System is to be filled with autogenous and/or allogeneic bone graft comprised of cancellous

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

and/or corticocancellous bone graft material, and is to be used with titanium alloy screws which accompany the implant.

## Summary of Technologies:

As established in this subject systems are substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to the predicate devices cleared in K151064 through comparison in areas including design, intended use, material composition, and function. The Alta ACDF System does not contain software or electrical equipment.

# Performance Data - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

The changes proposed did not require non-clinical testing in order to demonstrate substantial equivalence to the predicate devices.

# Performance Data - Summary of Clinical Test Conducted for Determination of Substantial Equivalence

Published retrospective clinical data for cervical interbody fusion devices similar to the subject device was completed to support this Premarket Notification. The published clinical outcomes demonstrated that the use of allograft (cancellous and/or corticocancellous bone graft) in anterior cervical interbody fusion poses no new risks to patients. No changes are being made to the existing device as subject of this Premarket Notification, aside from the expanded indications; therefore, no additional testing was required or performed.

## Substantial Equivalence:

The Alta ACDF System has the same or similar intended use, Indications for Use, technological characteristics, and principles of operation as the previously cleared Solitaire®-C Cervical Spacer System. C-Thru™ Anterior Spinal System, and Breckenridge® Small Intervertebral Body Fusion System (K151064). Thus, the subject device with expanded indications to include allograft (cancellous and/or corticocancellous bone graft) is substantially equivalent to the predicate devices.

# Conclusion:

In summary, the expanded indications for the Alta ACDF System have the same or similar: intended use, Indications for Use, technological characteristics, principles of operation and performance as the previously cleared Solitaire®-C Cervical Spacer System, C-Thru™ Anterior Spinal System, and Breckenridge® Small Intervertebral Body Fusion System (K151064). A retrospective evaluation of clinical literature demonstrates that expanding the indications of the subject system does not raise new questions of safety and efficacy and that the subject system is substantially equivalent to the previously cleared Solitaire®-C Cervical Spacer System, C-Thru™ Anterior Spinal System, and Breckenridge® Small Intervertebral Body Fusion System (K151064).