AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM

K100802 · Aesculap Implant Systems, Inc. · OVD · Jul 20, 2010 · Orthopedic

Device Facts

• Record ID: K100802
• Device Name: AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM
• Applicant: Aesculap Implant Systems, Inc.
• Product Code: OVD · Orthopedic
• Decision Date: Jul 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SIBD Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplement fixation is used. As an intervertebral body fusion device designed for use with autograft, the SIBD Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). Patients should be skeletally mature and must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap® Implant Systems device.

Device Story

The SIBD Spinal System is an implantable intervertebral body fusion device. It consists of a PEEK spacer with tantalum markers, secured to vertebral bodies via four titanium screws. The device is used in spinal fusion procedures at one or two contiguous lumbar levels (L2-S1). It is intended for use with autograft. The device is used by surgeons in a clinical setting. It provides mechanical stability to the spinal segment, facilitating fusion in patients with degenerative disc disease and spondylolisthesis. The variety of shapes and sizes allows for anatomical customization.

Clinical Evidence

No clinical data. Bench testing performed in accordance with ASTM F2077 and F2267, including static and dynamic axial compression, shear compression, torsion, subsidence, and expulsion testing.

Technological Characteristics

Materials: PEEK with tantalum markers and titanium screws. Design: Intervertebral body fusion device with integrated screw fixation. Testing: ASTM F2077/F2267. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis at one or two contiguous lumbar levels (L2-S1). DDD defined as discogenic back pain confirmed by history/radiography. Patients may have prior non-fusion surgery at involved levels. 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® Implant Systems PEEK Spinal Implant System (K071983)
• Synthes SynFix-LR Spacer (K072253)
• Biomet Spine Solitaire Anterior Spinal System (K081395)
• LDR Spine ROI Interbody Fusion System (K082262)
• Life Spine Stand Alone Spacer System (K091301)
• Surgicraft STALIF TT System (K073109)

Submission Summary (Full Text)

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K100802 Page 1 of 2

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

| Aesculap ® Implant Systems SIBD Spinal System<br>July 20, 2010 | JUL 20 2010 |
|----------------------------------------------------------------|-------------|
|----------------------------------------------------------------|-------------|

| COMPANY: | Aesculap® Implant Systems, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 3005673311 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle<br>610-984-9274 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | Aesculap® Implant Systems SIBD Spinal System |
| COMMON NAME: | Spinal Implants |
| CLASSIFICATION NAME: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| REGULATION NUMBER: | 888.3080 |
| PRODUCT CODE: | MAX |

### PURPOSE FOR PREMARKET NOTIFICATION

The purpose for this submission is to gain marketing clearance for the Aesculap® Implant Systems SIBD Spinal System.

#### SUBSTANTIAL EQUIVALENCE

Aesculap® Implant Systems, Inc. believes that the SIBD Spinal System is substantially equivalent to the Aesculap® Implant Systems PEEK Spinal Implant System (K071983), Synthes SynFix-LR Spacer (K072253), Biomet Spine Solitaire Anterior Spinal System (K081395), the LDR Spine ROI Interbody Fusion System (K082262), the Life Spine Stand Alone Spacer System (K091301), and the Surgicraft STALIF TT System (K073109).

#### DEVICE DESCRIPTION

The Aesculap® Implant Systems SIBD Spinal System is an implantable spinal device manufactured from polyetheretherketone (PEEK) with tantalum markers. The implant is secured to vertebral bodies by four titanium screws inserted through the anterior screw holes. The implants are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy.

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## INDICATIONS FOR USE

The SIBD Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplement fixation is incent.

As an intervertebral body fusion device designed for use with auto graft, the SIBD Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s).

Patients should be skeletally mature and must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aescular® In least Systems device.

# TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s))

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

## PERFORMANCE DATA

Static and dynamic testing of the Aesculap® Implant Systems SIBD Spinal System was performed in accordance with ASTM F2077/F2267 (static and dynamic axial compression, static & dynamic shear compression, static & dynamic torsion, subsidence, and expulsion testing) as recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. Testing results demonstrate the Aesculap® Implant Systems SIBD Spinal System is safe and effective.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

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

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

SEP 12 2011

Re: K100802

> Trade/Device Name: Aesculap® Implant Systems SIBD Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: June 10, 2010 Received: June 14, 2010

Dear Ms. Boyle:

This letter corrects our substantially equivalent letter of July 20, 2010.

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(ty the indications for use stated in the enclosure) to legally marketed preditate 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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act in clude 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 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

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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 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-fire number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Much A. Milkeison

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.

510(k) Number: K100802

Device Name: Aesculap® Implant Systems SIBD Spinal System

Indications for Use:

The SIBD Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplement fixation is used.

As an intervertebral body fusion device designed for use with autograft, the SIBD Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion and radiographic
spinal level(s). spinal level(s).

Patients should be skeletally mature and must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap® Implant Systems device.

| Prescription Use | X |
|----------------------|---|
| (per 21 CFR 801 100) | |

and/or Over-thee-Counter Use

(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 K100802