AESCULAP HYDROLIFT VBR SYSTEM

K083186 · Aesculap Implant System, Inc. · MQP · Mar 4, 2010 · Orthopedic

Device Facts

• Record ID: K083186
• Device Name: AESCULAP HYDROLIFT VBR SYSTEM
• Applicant: Aesculap Implant System, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Mar 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aesculap HydroLift 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 Aesculap HydroLift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aescular HydroLift VBR System may be used with bone graft. The Aesculap HydroLiff VBR System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Device Story

Adjustable vertebral body replacement (VBR) device; implanted into vertebral body space to improve spinal stability. Device height adjusted post-implantation via manual hydraulic pump or mechanical distractor; center column mechanically locked in place using locking screws. Features pivoting endplates for lordotic angulation; endplates include spikes/teeth to prevent migration. Used in thoracolumbar spine (T1-L5) for tumor or trauma cases. Operated by surgeons in clinical/OR settings. Provides anterior spinal column support; intended for use with supplemental fixation systems (e.g., Aesculap MACS TL or S4). Sterile saline used as hydraulic fluid.

Clinical Evidence

Bench testing only. Static and dynamic mechanical testing performed in accordance with ASTM F1717 as recommended by FDA guidance for spinal systems.

Technological Characteristics

Titanium alloy (Ti6ANV) construction. Mechanically adjustable height via manual hydraulic pump or mechanical distractor. Pivoting endplates with spikes/teeth for migration resistance. Sterile saline used as hydraulic fluid. Mechanical locking screw mechanism. Tested per ASTM F1717.

Indications for Use

Indicated for patients requiring partial or total vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma (fracture). Intended for use with supplemental spinal fixation and optional bone graft.

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

• SynEx Spacer System by Synthes (K003836)
• Lift VB Spinal System by Medtronic Sofamor Danek, Inc. (K010930)

Submission Summary (Full Text)

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510(k) Premarket Notification

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HydroLift VBR System

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

| | Aesculap HydroLift VBR System<br>01 March 2010 | MAR - 4 2010 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------|
| COMPANY: | Aesculap®Implant Systems, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 3005673311 | |
| CONTACT: | Matthew M. Hull<br>800-258-1946 (phone)<br>610-791-6882 (fax) | |
| TRADE NAME: | Aesculap HydroLift VBR System | |
| COMMON NAME: | Adjustable Vertebral Body Replacement Device | |
| CLASSIFICATION NAME: | Spinal Vertebral Body Replacement Device | |
| REGULATION NUMBER: | 868.3060 | |
| PRODUCT CODE: | MQP | |

## SUBSTANTIAL EQUIVALENCE

Aesculap® Implant Systems, Inc. believes that the Aesculap HydroLift VBR System is substantially equivalent to:

1) SynEx Spacer System by Synthes (K003836)

2) Lift VB Spinal System by Medtronic Sofamor Danek, Inc. (K010930)

## DEVICE DESCRIPTION

The Aesculap HydroLift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The center column of the device can be adjusted to the exact length required by the patients anatomy after implantation. Once it is adjusted to the desired length the column is mechanically locked in place. Primary components are manufactured from titanium alloy (Ti6ANV).

## INDICATIONS FOR USE

The Aesculap HydroLift 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 Aesculap HydroLift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aescular HydroLift VBR System may be used with bone graft. The Aesculap HydroLiff VBR System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

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HydroLift VBR System

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#### TECHNOLOGICAL CHARACTERISTICS(compared to Predicates)

The Aesculap HydroLift VBR System is a mechanically adjustable vertebral body replacement device as are the predicates. The HydroLift's height is precisely adjusted using either a manual hydraulic pump or a mechanical distractor. Once the device is at the desired height locking screws are employed to fix that position. The Synthes SynEx Spacer uses a ratcheting cylinder with discreet increments (2.5mm) and endplates to adjust it's height. Medtronic SD's Lift VB uses a screw type center cylinder with two endplates to adjust it's height. All three devices utilize locking screws to secure the desired height adjustment has been made. The HydroLift has pivoting endplates for precise lordotic anqulation while the predicate devices offer a selection of endplates at set lordotic angles. The endplates of all three devices utilize small spikes and/or teeth to prevent migration. The material used for the Aesculap device is the same as that used to manufacture the predicate devices. Sterile saline solution serves as the fluid for the hydraulic mechanism.

# PERFORMANCE DATA

Static and dynamic testing of the Aesculap HydroLift VBR System was performed in accordance with ASTM F1717 as recommended by the FDA Guidance for Spinal System 510(k)'s.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Aesculap® Implant Systems, Inc. % Mr. Matthew M. Hull, RAC Manager, Regulatory Affairs 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K083186

Trade/Device Name: Aesculap HydroLift VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 31, 2009 Received: September 01, 2009

Dear Mr. Hull:

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.

MAR ~ 4 2010

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

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Page 2 - Mr. Matthew M. Hull, RAC

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely, yours,

Mark A. Wilkerson

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

Enclosure

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#### INDICATIONS FOR USE STATEMENT A.

KUS 31860 510(k) Number:_

Device Name:

Indications for Use:

The Aesculap HydroLift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, or unstable vertebral body due to tumor or trauma (i.e. fracture). The Aesculap HydroLift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap HydroLift VBR System may be used with bone graft. The Aesculap HydroLift VBR System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Prescription Use (per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

| 510(k) Number | K083186 |
|---------------|---------|
|---------------|---------|

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