SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM

K130146 · Synthes (Usa), LLC · NDN · May 20, 2013 · Orthopedic

Device Facts

• Record ID: K130146
• Device Name: SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
• Applicant: Synthes (Usa), LLC
• Product Code: NDN · Orthopedic
• Decision Date: May 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synflate Vertebral Balloon System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

Device Story

System comprises vertebral access kit, biopsy kit, balloon-catheter, stiffening wire, syringe with luer lock, and inflation system. Used in percutaneous vertebral augmentation procedures to reduce fractures or create voids in spinal cancellous bone. Operated by physicians in clinical settings. Balloon inserted into vertebral body; inflated via inflation system to create void or reduce fracture; void subsequently filled with cleared PMMA bone cement. Benefits include restoration of vertebral height and stabilization of fractures. Provided sterile.

Clinical Evidence

Bench testing only. Mechanical and biomechanical testing assessed balloon pressure, volume limitations, burst characteristics, and void creation/fracture reduction capability. No clinical data required.

Technological Characteristics

System includes balloon-catheter, stiffening wire, syringe, and inflation system. Mechanical device; non-powered. Provided sterile. No software or electronic components.

Indications for Use

Indicated for patients requiring reduction of spinal fractures or creation of a void in cancellous bone during percutaneous vertebral augmentation procedures, such as kyphoplasty, using cleared PMMA bone cements.

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

• Synthes Vertebral Body Balloon (VBB) System (K110604)
• Kyphon KyphX Xpander Inflatable Bone Tamp (K041454)

Submission Summary (Full Text)

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® SYNTHES®
Spine

Spine

# MAY 2 0 2013

| 6 | 510(k) Summary | MAY 2 |
|---|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Name of Firm: | Depuy Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
| | 510(k) Contact: | Stacey Bonnell<br>Senior, Regulatory Affairs Specialist - Depuy Synthes Spine<br>Telephone: [phone] Facsimile: 610-719-5102<br>Email: [e-mail] |
| | Date Prepared: | January 18, 2013 |
| | Trade Name: | Synthes Synflate Vertebral Balloon System |
| | Classification: | Orthopaedic and Rehabilitation Devices Panel<br>Class II<br>21 CFR 888.1100 - Arthroscope, Orthopedic<br>Class II; Product Code HRX<br>21 CFR 888.3027 - Cement, Bone, Vertebroplasty<br>Class II; Product Code NDN |
| | Predicate Devices: | Synthes Vertebral Body Balloon (VBB) System (K110604)<br>Kyphon KyphX Xpander Inflatable Bone Tamp (K041454) |
| | Device Description: | The Synflate Vertebral Balloon System is a comprehensive array of<br>instrumentation (Vertebral Access Kit as well as a Biopsy Kit), vertebral<br>augmentation balloons (inclusive of balloon-catheter, stiffening wire,<br>and syringe with luer lock), and Inflation System (previously cleared via<br>K110604). All instruments and implants are provided sterile and<br>packaged separately. |
| | | The Synflate balloon catheter includes a stiffening wire and syringe with<br>luer lock. The balloon is inflated within the vertebral body via the<br>Inflation System. |
| | | The Synflate balloon catheter is intended to be used for the reduction of<br>fractures and/or creation of a void in cancellous bone in the spine. This<br>includes use during percutaneous vertebral augmentation. The system is<br>to be used with cleared spinal polymethylmethacrylate (PMMA) bone<br>cements indicated for use during percutaneous vertebral augmentation<br>procedures, such as kyphoplasty. |
| | Intended Use /<br>Indications for Use: | The Synflate Vertebral Balloon System is intended to be used for the<br>reduction of fractures and/or creation of a void in cancellous bone in the<br>spine. This includes use during percutaneous vertebral augmentation.<br>The system is to be used with cleared spinal polymethylmethacrylate<br>(PMMA) bone cements indicated for use during percutaneous vertebral<br>augmentation procedures, such as kyphoplasty |

Synthes Synflate Vertebral Balloon System Traditional 510(k)

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| Comparison of the<br>technological<br>characteristics of the<br>device to the<br>predicate device: | The design features, material, and indications for use of the Synflate<br>System are substantially equivalent to the predicate devices identified.<br>Additionally, the safety and effectiveness of this system is adequately<br>supported by documentation within this premarket notification. |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data<br>(Non-clinical and/or<br>Clinical) | Mechanical and biomechanical testing was performed in order to<br>provide data to support a substantial equivalence determination. These<br>tests were performed to characterize the properties and functionality of<br>the Synflate System, as well as to allow comparison with established<br>acceptance criteria. Mechanical and biomechanical testing was<br>performed to assess balloon pressure and volume limitations, burst<br>characteristics, and ability of the device to be used for the reduction of<br>fractures and/or creation of a void in cancellous bone. The conclusions<br>drawn from testing demonstrate that the Synflate System is as safe and<br>effective as the predicate devices identified.<br><br>Clinical data was not needed to demonstrate the safety and effectiveness<br>of this system. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

## May 20, 2013

Depuy Synthes Spine % Ms. Stacev Bonnell Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K130146

Trade/Device Name: Synthes Synflate Vertebral Balloon System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: March 26, 2013 Received: March 27, 2013

Dear Ms. Bonnell:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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### Page 2 - Ms. Stacey Bonnell

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/7 description: The image shows the name "Erin I. Keith" in a stylized font. The letters "I" and "." are designed with concentric lines, creating a unique visual effect. The name is presented in a clear, bold typeface, making it easily readable.

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

Enclosure

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## @ SYNTHES Spine

#### 5 Indications for Use Statement

510(k) Number:

Device Name: Synthes Synflate Vertebral Balloon System

Indications for Use:

The Synflate Vertebral Balloon System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with clearad spiral polymethylmethacrylate (PMMA) bone cements indicated for use during percutated us vertebral augmentation procedures, such as kyphoplasty.

#### Prescription Use × (21 CFR 801 Subpart D)

AND / OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne - A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130146

Synthes Synflate Vertebral Balloon System Traditional 510(k)