AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM

K083311 · Aesculap Implant Systems, Inc. · ODP · Mar 4, 2009 · Orthopedic

Device Facts

• Record ID: K083311
• Device Name: AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
• Applicant: Aesculap Implant Systems, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Mar 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Aesoulap 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 CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion procedures at one level (C3-C7) 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. 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 is also intended for use with autogenous bone graft. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Aesculap device.

Device Story

Cervical/thoracolumbar intervertebral body fusion and vertebral body replacement system; implanted into vertebral space to improve spinal stability and support fusion; used with supplemental fixation (e.g., Aesculap S4 System) and bone graft; components available in various sizes to match patient anatomy; implanted by surgeons in clinical settings; provides structural support to restore vertebral height and facilitate fusion; benefits patients by stabilizing spine and relieving symptoms associated with DDD or vertebral trauma.

Clinical Evidence

Bench testing only. Static and dynamic mechanical testing performed in accordance with ASTM F2077 and F1717 per FDA Class II Special Controls Guidance Document for Intervertebral Body Fusion Devices.

Technological Characteristics

Manufactured from PEEK-Optima (ASTM F2026). Circular implants with flattened sides. Mechanical performance validated via ASTM F2077 and F1717. Standalone implant system used with supplemental fixation.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one level (C3-C7) requiring spinal fusion, or patients with thoracolumbar (T1-L5) vertebral body collapse/instability due to trauma/tumor requiring replacement. Requires 6 weeks prior non-operative treatment for DDD.

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 and Intervertebral Body Fusion Systems (K060762 & K071983)
• Spinal Elements Crystal cervical interbody fusion devices (K073351)

Submission Summary (Full Text)

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K083311

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

# Aesculap CeSpace PEEK Spinal Implant System

7 November 2008

MAR - 4 2009

| 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 CeSpace PEEK Spinal Implant System |
| COMMON NAME: | Intervertebral Fusion Device w/ Bone Graft, Cervical |
| CLASSIFICATION NAME: | Orthosis, Spinal Intervertebral Fusion |
| REGULATION NUMBER: | 888.3080 |
| PRODUCT CODE: | ODP, MQP |

# SUBSTANTIAL EQUIVALENCE

Aesculap® Implant Systems, Inc. believes that the Aesculap Cespace PEEK Spinal Implant System is substantially equivalent to the Aesculap PEEK VBR and Intervertebral Body Fusion Systems (K060762 & K071983), the Spinal Elements Crystal cervical interbody fusion devices (K073351).

# DEVICE DESCRIPTION

The Aesculap CeSpace PEEK Spinal Implant System is a cervical 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 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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1083311

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When used as an Intervertebral Body Fusion System:

The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion procedures at one level (C3-C7) 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. 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 is also intended for use with autogenous bone graft.

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

# TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}

The implants in the Aesculap CeSpace 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

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

MAR 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap® Implant System, Inc. % Mr. Matthew M. Hull 3733 Corporate Parkway Center Valley. Pennsylvania 18034

MAR 4 2009

Re: K083311

Trade/Device Name: Aesculap CeSpace PEEK Intervetebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP Dated: February 10, 2009 Received: February 11, 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.

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 M. 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 the reporting 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. Milke

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.

#### 1083311 510(k) Number:

# Device Name: Aesculap CeSpace PEEK Intervertebral Body Fusion 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 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 Aesoulap 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 CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion procedures at one level (C3-C7) 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. 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 is also intended for use with autogenous bone graft.

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

Prescription Use X _______ and/or Over-the-Counter 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)

NDCS FEDERATION LTD.

and Neurological Device

510(k) Number 4683311