AIS MODULIFT VBR SYSTEM

K142150 · Aesculap Implant System, Inc. · MQP · Oct 29, 2014 · Orthopedic

Device Facts

• Record ID: K142150
• Device Name: AIS MODULIFT VBR SYSTEM
• Applicant: Aesculap Implant System, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Oct 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AIS Modulift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap Modulift VBR System may be used with bone graft.

Device Story

Adjustable vertebral body replacement (VBR) device; implanted into vertebral body space to restore stability. System consists of spacers and footplates of varying heights/angles; features axial hole for bone graft packing; spikes on footplates for vertebral anchoring. Height adjusted post-implantation; column mechanically locked via grub screws. Used in thoracolumbar spine (T1-L5) for tumor or trauma cases. Requires supplemental spinal fixation (e.g., Aesculap MACS TL or S4 Systems).

Clinical Evidence

Bench testing only. Expulsion testing performed per ASTM Draft Standard F-04.25.02.02 demonstrated that the device meets or exceeds the performance of predicate devices.

Technological Characteristics

Mechanically adjustable VBR system. Materials: Titanium alloy (Ti6Al4V) per ASTM F-136; Cobalt chrome (CoCr) per ASTM F1537. Features spacers, footplates with spikes, and locking grub screws. Axial hole for bone graft. Available in various lordotic/kyphotic angles.

Indications for Use

Indicated for patients requiring partial or total vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma-induced collapse, damage, or instability. Must be used with supplemental spinal fixation.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Aesculap Modulift VBR System (K110864/K133802)
• Ulrich Obelisc VBR Systems (K060416)

Submission Summary (Full Text)

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

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

October 29, 2014

Aesculap® Implant Systems, Incoporated Ms. Lisa M. Boyle Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K142150

Trade/Device Name: AIS Modulift VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP Dated: August 4, 2014 Received: August 5, 2014

Dear Ms. Boyle:

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

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

Page 2 - Ms. Lisa M. Boyle

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/Resourcesfor You/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.

Ronald P. Jean -S for

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) K142150

Device Name AIS Modulift VBR System

#### Indications for Use (Describe)

The AIS Modulift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap Modulift VBR System may be used with bone graft.

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

| <span style="font-size: 100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|

#### 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}------------------------------------------------

#### B. 510(k) SUMMARY (as required by 21 CFR 807.92)

#### Aesculap Implant Systems, LLC. (AIS) Modulift (Modulift) VBR System October 28, 2014

| COMPANY: | Aesculap®Implant Systems, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 3005673311 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle<br>800-258-1946 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | AIS Modulift VBR System |
| COMMON NAME: | Adjustable Vertebral Body Replacement Device |
| CLASSIFICATION NAME: | Spinal Vertebral Body Replacement Device |
| REGULATION NUMBER: | 888.3060 |
| PRODUCT CODE: | MQP |

## PURPOSE FOR PREMARKET NOTIFICATION

The AIS Modulift VBR System described in this submission introduces medium and large (15°) footplates that are used with the VBR's currently cleared in the existing product line under K133802 /K110864.

## DEVICE DESCRIPTION

The AIS Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.

## INDICATIONS FOR USE

The AIS Modulift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with

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

supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The AIS Modulift VBR System may be used with bone graft.

## TECHNOLOGICAL CHARACTERISTICS(compared to Predicates)

As is established in this submission, the AIS Modulift VBR System is a mechanically adjustable vertebral body replacement device that is substantially equivalent to other predicate devices cleared by FDA. The subject device is shown to be substantially equivalent and has the same technological characteristics to its predicate devices through comparison in design, intended use, material composition, function and range of sizes.

## PERFORMANCE DATA

As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate that the AIS Modulift VBR System is substantially equivalent to other predicate devices. The following testing was performed:

- Expulsion per ASTM Draft Standard F-04.25.02.02
The results of the testing showed that the subject AIS Modulift VBR System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.

## PREDICATE DEVICE

- Primary Predicate: Aesculap Modulift VBR System (K110864/K133802) .
- Ulrich Obelisc VBR Systems (K060416) .