AESCULAP CESPACE XP

K123909 · Aesculap Implant System, Inc. · ODP · Apr 15, 2013 · Orthopedic

Device Facts

• Record ID: K123909
• Device Name: AESCULAP CESPACE XP
• Applicant: Aesculap Implant System, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Apr 15, 2013
• 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 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 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

CeSpace XP is a cervical intervertebral body fusion device implanted into the vertebral space to improve stability and support fusion. Components are PEEK implants with a titanium layer and vacuum plasma spray coating (Plasmapore). Tantalum markers are included for radiographic visualization. The device is used by surgeons in clinical settings to restore vertebral height and achieve decompression. It is intended for use with supplemental spinal fixation (e.g., Aesculap S4 System) and autogenous bone graft. By providing structural support and a surface for fusion, the device aims to alleviate discogenic pain and stabilize the spinal segment.

Clinical Evidence

Bench testing only. Testing included static and dynamic torsion, axial compression, and shear resistance per ASTM F2077; subsidence per ASTM F2267; and coating characterization per ASTM F1854, F1147, F1044, F1160, and F1978.

Technological Characteristics

Materials: PEEK, titanium layer, vacuum plasma spray coating (Plasmapore per ISO 5832-3), Tantalum markers (ASTM F560). Form factor: Circular with flattened sides, various sizes. Energy source: None (mechanical). Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one level (C3-C7) or for thoracolumbar (T1-L5) vertebral body replacement due to tumor or trauma. Requires 6 weeks of 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 CeSpace PEEK VBR and Intervertebral Body Fusion Systems (K083311)

Submission Summary (Full Text)

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# APR 1 5 2013

CeSpace PEEK Intervertebral Body Fusion System (Plasmapore® Coated)

K123909

Page 1 of 3

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

## Aesculap® Implant Systems(AIS) - CeSpace XP Intervertebral Body Fusion System

#### December 18, 2012

| COMPANY: | Aesculap® Implant Systems (AIS), LLC.<br>3773 Corporate Parkway |
|----------|--------------------------------------------------------------------------|
| | Center Valley, PA 18034<br>Establishment Registration Number: 300567331- |

Lisa M. Boyle, Sr. Regulatory Affairs Specialist CONTACT: 610-984-9274 (phone) 610-791-6882 (fax) [e-mail]

| TRADE NAME: | AIS CeSpace XP Intervertebral Body Fusion System |
|----------------------|--------------------------------------------------|
| COMMON NAME: | Intervertebral Body Fusion Device |
| CLASSIFICATION NAME: | Orthosis, Spinal Intervertebral Fusion |
| REGULATION NUMBER: | 888.3080 |
| PRODUCT CODE: | ODP |
| REVIEW PANEL: | Orthopedics |

### 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 vertebrail 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 CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion erodial in Shape Min Hattoned elessed telefally 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.

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CeSpace PEEK Intervertebral Body Fusion System (Plasmapore® Coated) K123909

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## DEVICE DESCRIPTION

The Aesculap CeSpace XP Intervertebral Body Fusion System is a cervical intervertebral I no fusiondevice that is implanted into the vertebral body space to improve stability of bour fusional hile supporting fusion. Components are offered in a variety of sizes to meet the requirements of the individual patient anatomy. Components are manufactured from the requirements of the Inalifical P026) with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have Tantalum markers per ASTM F-560.

# TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The components of the CeSpace XP Intervertebral Body Fusion System are offered in the same range of shapes and sizes as the predicate device. The material used for the the same Tango of Systems device is the same as that used to manufacture the predicate devices. The only difference between the predicate device and the subject produce is the titanium layer and a vacuum plasma spray coating (Plasmapore®).

## PERFORMANCE DATA

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

- Static and dynamic torsion per ASTM F2077 .
- Static and dynamic axial compression per ASTM F2077 .
- Shear resistance evaluation .
- . Subsidence per ASTM F2267

In addition to FDA's Spine Guidance, Aesculap has also completed non-clinical testing in addition to in the "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements." The following tests were performed:

- Microstructure of the coating per ASTM F1854 .
- Static Tensile Strength per ASTM F1147 .
- Static Shear Strength per ASTM F1044 .
- Shear Fatigue Test per ASTM F1160 .
- · Abrasion Resistance per ASTM F1978

The results of these tests showed that the CeSpace XP Spinal Implant System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.

## SUBSTANTIAL EQUIVALENCE

AIS believes that the Cespace XP Intervertebral Body Fusion System is substantially All believes that the Ocepace Al " in the Aesculap CeSpace PÉEK VBR and Intervertebral Body

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K123909 Page 3 of 3

Fusion Systems (K083311). The Plasmapore® coating has been used and cloared in a number of legally marketed product lines manufactured by Aesculap (hip, knee, and spinal implants) for many years.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background of the image is white.

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal 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 three curved lines representing its wings or body.

#### Public Health Service

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

### April 15, 2013

Aesculap Implant Systems, Incorporated % Ms. Lisa Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K123909

Trade/Device Name: Aesculap® Implant Systems (AIS) - CeSpace XP Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 13, 2013 Received: March 14, 2013

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

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### Page 2 - Ms. Lisa Boyle

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 yours,

Image /page/4/Picture/7 description: The image shows the name "Erin I. Keith" in a stylized font. The first name, "Erin," is written in a standard, bold typeface. The middle initial, "I.," and the last name, "Keith," are rendered in a more decorative, outlined font, giving the overall name a unique and visually distinct appearance. The design suggests a logo or personal branding element.

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

Enclosure

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CeSpace PEEK Intervertebral Body Fusion System (Plasmapore® Coated)

Page 1 of 1

#### INDICATIONS FOR USE STATEMENT A.

510(k) Number:_ K123909

## Device Name: Aesculap® Implant Systems (AIS) – CeSpace XP 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 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 or the upinal one and the Intent 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 orrocedures 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 The Aesculap PEEK Spinal Implant System is also intended for use with System. 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

(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)

> Anton E. Dmitriev. PhD Division of Orthopedic Devices