ARCUATE VERTEBRAL AUGMENTATION SYSTEM

K070527 · Medtronic Sofamor Danek · NDN · May 4, 2007 · Orthopedic

Device Facts

• Record ID: K070527
• Device Name: ARCUATE VERTEBRAL AUGMENTATION SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: NDN · Orthopedic
• Decision Date: May 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ARCUATE™ Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma.

Device Story

ARCUATE™ Vertebral Augmentation System is a set of manual instruments for percutaneous delivery of polymethylmethacrylate (PMMA) bone cement to the spine. Used in vertebroplasty procedures to treat painful vertebral compression fractures. System includes manual instruments and VISIOPLAST™ Spine Cement. Operated by physicians in a clinical setting. Provides a mechanical means to inject cement into the vertebral body to stabilize fractures and alleviate pain.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical instruments for percutaneous delivery of PMMA bone cement. System includes VISIOPLAST™ Spine Cement. No electronic components, software, or energy sources. Mechanical delivery mechanism.

Indications for Use

Indicated for treatment of painful pathological vertebral body fractures resulting from osteoporosis, benign lesions, or malignant lesions (metastatic cancer, myeloma).

Regulatory Classification

Identification

Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”

Predicate Devices

• ARCUATE™ Vertebral Augmentation System (K063248)
• EQUESTRA™ Fluid Delivery System (K040483)
• Kit Mendec Spine and Delivery System (K062452)
• EBI Vertebroplasty System (K060148)
• Vertefix® Vertebroplasty Procedure Set (K042691)
• Disco-O-Tech CONFIDENCE Cement System (K062424)

Reference Devices

• VISIOPLAST™ Spine Cement (K042415)

Submission Summary (Full Text)

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K070527

# ARCUATE™ Vertebral Augmentation System 510(k) Summary April 2007

| I. | Company: | Medtronic Sofamor Danek USA, Inc. |
|----|----------|-----------------------------------|
| | | 1800 Pyramid Place |
| | | Memphis, TN 38132 |

MAY - 4 2007

- Christine Scifert Contact: Group Director, Regulatory Affairs [phone]
- ARCUATE™ Vertebral Augmentation System Proposed Proprietary Trade Name: II. Classification Name: Methyl Methacrylate for Vertebroplasty Orthopedic Cement Delivery System NDN. KIH Product Code: 888.3027 and 888.4200 Regulation No .:

# Product Description/Purpose of Application III.

The purpose of this application is to include additional instruments to the previously cleared ARCUATE™ Vertebral Augmentation System (K063248). The ARCUATE™ Vertebral Augmentation System consists of a variety of manual instruments which provides physicians with a means to percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the spine in vertebroplasty procedures. The ARCUATE™ Vertebral Augmentation System kits are packaged with VISIOPLAST™ Spine Cement, which has been previously cleared by the FDA for use in the treatment of painful vertebral compression fractures.

### IV. Indications

The ARCUATE™ Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma.

# V. Substantial Equivalence

Documentation was provided which demonstrated the subject ARCUATE™ instruments to be substantially equivalent to previously cleared systems such as the ARCUATE™ Vertebral Augmentation System (K063248, SE 03/13/07, the EQUESTRA™ Fluid Delivery System, (K040483, SE 06/23/04), the Kit Mendec Spine and Delivery System (Tecres SpA, K062452, SE 09/21/06), the EBI Vertebroplasty System (K060148, SE 03/16/06), the Vertefix® Vertebroplasty Procedure Set (K042691, SE 11/08/05) and the Disco-O-Tech CONFIDENCE Cement System (K062424, SE 0914/06). The VISIOPLAST™ Spine Cement packaged with this

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system was cleared by the agency for use in the treatment of painful vertebral compression fractures in K042415, SE 06/09/05.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three overlapping wings, symbolizing health, services, and security. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AY = 4 7007

Medtronic Sofamor Danek % Ms. Christine Scifert Director, Regulatory Affairs 1800 Pvramid Place Memphis, Tennessee 38132

Re: K070527

Trade/Device Name: ARCUATE™ Vertebral Augmentation System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, KIH Dated: February 22, 2007 Received: February 23, 2007

Dear Ms. Scifert:

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 ass outted in also encreat 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 n your at 110 to 11 also 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. Christine Scifert

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours.

barbara Buend
TS

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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April - 2007

510(k) Number_

Device Name:

Indications for Use: The ARCUATE™ Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma.

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sebeart BuelsingBaxm

(Division Sign) Division of General, Restorative, and Neurological Devices

**510(k) Number** K070527