ARDIS SPACER

K073202 · Abbott Spine, Inc. · MAX · Jan 30, 2008 · Orthopedic

Device Facts

• Record ID: K073202
• Device Name: ARDIS SPACER
• Applicant: Abbott Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jan 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ardis™ Spacer is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. The Ardis™ Spacer is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

Device Story

Ardis™ Spacer is a hollow intervertebral body fusion device; implanted via posterior or transforaminal approach; used singly or in pairs with supplemental fixation. Designed for lumbosacral (L2-S1) fusion in patients with degenerative disc disease. Device provides structural support to facilitate fusion when packed with autogenous bone graft. Used by surgeons in clinical/OR settings. Benefits include stabilization of spinal segments and promotion of fusion in symptomatic patients failing conservative therapy.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Hollow intervertebral body fusion device; metallic construction; designed for posterior or transforaminal implantation; used with supplemental fixation.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis. Includes patients with prior non-fusion spinal surgery at the involved level. Requires six months of prior non-operative treatment. Used with autogenous bone graft.

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

• BAK™ Interbody Fusion System (P950002)

Submission Summary (Full Text)

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K073202

JAN 30 Lan i

## ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter:

Abbott Spine Inc.

ESTABLISHMENT REGISTRATION Number:

CONTACT PERSON:

1649384

Maritza Elias Requlatory Affairs Specialist Telephone: [phone] Fax: [phone]

DATE:

Trade Name:

Product Code:

DEVICE CLASSIFICATION:

CLASSIFICATION NAME:

Classification Reference:

PREDICATE DEVICE:

Device Description:

INDICATIONS:

Ardis™ Spacer

January 16, 2008

MAX

Class II

Spinal Intervertebral Body Fusion Device

21 CFR § 888.3080

BAK™ Interbody Fusion System (P950002)

Ardis™ Spacer is a hollow device intended for use as an intervertebral body fusion device in the lumbosacral region (L2-S1) of the spine.

The Ardis™ Spacer is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous nonfusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.

The Ardis™ Spacer is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

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## SUBSTANTIAL EQUIVALENCE:

Engineering evaluations and bench testing were conducted to assess the physical and mechanical properties of the subject device. These results demonstrate that the performance of the Abbott Spine Ardis™ Spacer, when compared with other available intervertebral body fusion devices with similar indications, intended use and materials of manufacture is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

JAN 30 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Abbott Spine, Inc. % Ms. Maritza Elias Regulatory Affairs Specialist 5301 Riata Park Court, Bldg F Austin, TX 78727

Re: K073202

Trade/Device Name: ArdisTM Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: November 7, 2007 Received: November 13, 2007

Dear Ms. Elias:

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 - Ms. Maritza Elias

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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M Mulkerson

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

510(k) Number (if known): K073202

Device Name:

Abbott Spine Ardis TM Spacer

## Indications for Use:

The Ardis™ Spacer is indicated for use with autogenous bone graff as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.

The Ardis™ Spacer is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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and Neurological Devices

**510(k) Number** K073202