AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE

K071983 · Aesculap Implant Systems, Inc. · MAX · May 1, 2008 · Orthopedic

Device Facts

• Record ID: K071983
• Device Name: AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE
• Applicant: Aesculap Implant Systems, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: May 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

When used as a Vertebral Body Replacement Device: The Aesculap PEEK Spinal Implant 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) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft. When used as an Intervertebral Body Fusion System: The Aesculap PEEK Spinal Implant System consists of A-Space (semi-circular), ProSpace (bullet), and T-Space (curved) components. These implants are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The Aesculap PEEK Spinal Implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap device.

Device Story

Intervertebral body fusion/vertebral body replacement device; implanted into vertebral space to provide stability and support fusion; used in thoracolumbar/lumbosacral spine. Components (A-Space, ProSpace, T-Space) available in various shapes/sizes to match patient anatomy. Used with supplemental spinal fixation systems and bone graft. Implanted by surgeons during spinal procedures; restores vertebral height and achieves anterior decompression. Benefits include spinal stabilization and fusion support.

Clinical Evidence

Bench testing only. Static and dynamic mechanical testing performed in accordance with ASTM F2077 and/or F1717 per FDA Class II Special Controls Guidance.

Technological Characteristics

Material: PEEK-Optima (ASTM F2026). Form factor: Intervertebral body fusion/replacement components (A-Space, ProSpace, T-Space). Mechanical testing: ASTM F2077, ASTM F1717.

Indications for Use

Indicated for thoracolumbar (T1-L5) vertebral body replacement due to tumor/trauma; and lumbosacral (L2-S1) spinal fusion in skeletally mature patients with degenerative disc disease (DDD) with/without Grade 1 spondylolisthesis/retrolisthesis. Requires 6 months prior 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

• Aesculap PEEK VBR System (K060762)
• Spinal Elements Lucent (K071724)
• Spinal Elements Lucent Magnum (K073348)

Submission Summary (Full Text)

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Aesculap ***PEEK Spinal Implant System***

Page 1 of 2

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

MAY - 1 2008

# Aesculap PEEK Spinal Implant System 3 March 2008

| 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 PEEK Spinal Implant System |
| COMMON NAME: | Intervertebral Body Fusion Device |
| CLASSIFICATION NAME: | Orthosis, Spinal Intervertebral Fusion |
| REGULATION NUMBER: | 888.3080 |
| PRODUCT CODE: | MAX |

# SUBSTANTIAL EQUIVALENCE

Aesculap® Implant Systems, Inc. believes that the Aesculap PEEK Spinal Implant System is substantially equivalent to the Aesculao PEEK VBR System (K060762), the Spinal Elements Lucent and Lucent Magnum Interbody Fusion devices (K071724 & K073348).

# DEVICE DESCRIPTION

The Aesculap PEEK Spinal Implant System is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK - Optima (per ASTM F2026).

## INDICATIONS FOR USE

When used as a Vertebral Body Replacement Device:

The Aesculap PEEK Spinal Implant 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) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.

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Aesculap PEEK Spinal Implant System

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### When used as an Intervertebral Body Fusion System:

The Aesculap PEEK Spinal Implant System consists of A-Space (semi-circular), ProSpace (bullet), and T-Space (curved) components. These implants are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 Spondy/olisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The Aesculap PEEK Spinal Implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap device.

## TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

The components of the Aesculap PEEK Spinal Implant System are offered in the same range of shapes and sizes as the predicate devices. The material used for the Aesculap device is the same as that used to manufacture the predicate devices.

## PERFORMANCE DATA

Static and dynamic testing of the Aesculap PEEK Spinal Implant System was performed in accordance with ASTM F2077 and/or F1717 as recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY - 1 2008

Aesculap Implant Systems, Incorporated % Mr. Matthew Hull Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, PA 18034

Re: K071983

Trade/Device Name: Aesculap PEEK Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 16, 2008 Received: April 16, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Matthew Hull

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT A.

## 510(k) Number: K071983

## Device Name: Aesculap PEEK Spinal Implant System

## Indications for Use:

## When used as a Vertebral Body Replacement Device:

The Aesculap PEEK Spinal Implant 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) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.

## When used as an Intervertebral Body Fusion System:

The Aesculap PEEK Spinal Implant System consists of A-Space (semi-circular), ProSpace (bullet), and T-Space (curved) components. These implants are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The Aesculap PEEK Spinal Implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap device.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(ber 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)

Neil RPOgL for nx

Division of General, Restorative, and Neurological Devices

510(k) Number_Ko71983