ALTERA SPACER

K140411 · Globus Medical, Inc. · MAX · Jul 1, 2014 · Orthopedic

Device Facts

• Record ID: K140411
• Device Name: ALTERA SPACER
• Applicant: Globus Medical, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jul 1, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ALTERA™ Spacer is an interbody fusion device in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back 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) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). The ALTERA™ Spacer is to be filled with autogenous bone graft material. The device is intended to be used with supplemental fixation.

Device Story

ALTERA™ Spacer is an expandable lumbar interbody fusion device; provides structural stability following discectomy. Device accommodates posterior or transforaminal surgical approaches; allows articulation upon insertion; features superior/inferior protrusions to grip vertebral endplates and resist expulsion. Surgeon fills device with autogenous bone graft material; requires use with supplemental fixation. Device provides continuous expansion within a range to fit patient anatomy. Used in clinical settings by surgeons to treat degenerative disc disease; benefits patients by restoring disc space stability and facilitating fusion.

Clinical Evidence

Bench testing only. Mechanical testing included static and dynamic compression, static and dynamic compression shear, and subsidence testing performed in accordance with FDA guidance for Intervertebral Fusion Devices and ASTM standards (F2077, F2267).

Technological Characteristics

Expandable interbody fusion device. Materials: Titanium alloy (ASTM F136, F1295, F1472); internal components: PEEK polymer (ASTM F2026) and cobalt chromium molybdenum alloy (ASTM F1537). Mechanical expansion mechanism. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1), including those with up to Grade 1 spondylolisthesis or retrolisthesis, who have failed at least 6 months 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

• CALIBER® Spacer (K102293)
• PATRIOT® Spacer (K072970 & K122097)
• CoAlign Innovation AccuLIF® TL Cage (K113465)

Submission Summary (Full Text)

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

K140411 page 1 of 2

## 510(k) SUMMARY: ALTERA™ Spacer

# JUL 0 1 204

| Company: | Globus Medical Inc. |
|----------|-------------------------------|
| | 2560 General Armistead Avenue |
| | Audubon, PA 19403 |
| | [phone] |

Contact: Christina Kichula Group Manager, Regulatory Affairs

Date Prepared: February 17, 2014

Device Name: ALTERA™ Spacer

Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Code: MAX Regulatory Class: II, Panel Code: 87

- CALIBER® Spacer (K102293) Predicate(s): PATRIOT® Spacer (K072970 & K122097) CoAlign Innovation AccuLIF® TL Cage (K113465)
#### Purpose:

The purpose of this submission is to request clearance for the ALTERA™ Spacer.

## Device Description:

The ALTERA™ Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The ALTERA™ Spacer accommodates various surgical approaches to the lumbar spine (posterior or transforaminal [posterolateral]) and allows articulation upon insertion. The device is available in various height ranges, allowing continuous expansion within the range, to fit the anatomical needs of a wide variety of patients. This device is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

The ALTERA™ Spacer is made from titanium allov, as specified in ASTM F136. F1295, and F1472. Internal components are made from radiolucent PEEK polymer and cobalt chromium molybdenum alloy, as specified in ASTM F2026 and F1537.

#### Indications for Use:

The ALTERA™ Spacer is an interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of

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

the lumbosacral spine (L2-S1). DDD is defined as discogenic back 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) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The ALTERA™ Spacer is to be filled with autogenous bone graft material. The device is intended to be used with supplemental fixation.

## Performance Data:

Mechanical testing (static and dynamic compression, static and dynamic compression shear, and subsidence) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device." June 12, 2007. ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices. Results demonstrate that the ALTERA™ Spacer performs equivalently to or better than the predicate CALIBER® Spacer.

## Basis for Substantial Equivalence:

The ALTERA™ Spacer is similar to the predicate systems with respect to technical characteristics, performance, design, materials, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. The ALTERA™ Spacer's safety and effectiveness profile is similar to the cited predicates.

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the side. The bird is composed of thick, curved lines, giving it a modern and abstract appearance.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 1, 2014

Globus Medical, Incorporated Ms. Christina Kichula Group Manager. Regulatory Affairs 2560 General Armistead Avenue Audubon. Pennsylvania 19403

Re: K140411

Trade/Device Name: ALTERATM Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 30, 2014 Received: June 2. 2014

Dear Ms. Kichula:

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

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

#### Page 2 - Ms. Christina Kichula

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 331-542 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/dcfault.htm.

Sincerely yours,

# Ronald P. Jean -S for

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

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K140411

## Device Name

ALTERA™ Spacer

#### Indications for Use (Describe)

The ALTERA™ Spacer is an interbody fusion device in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back 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) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s).

The ALTERATM Spacer is to be tilled with autogenous bone graft material. The device is intended to be used with supplemental fixation.

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

## Dinitriev. Pr

**A**

Division of

FORM FDA 3881 (1/14)

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 EF

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