VBB SYSTEM

K110604 · Synthes · NDN · Dec 13, 2011 · Orthopedic

Device Facts

• Record ID: K110604
• Device Name: VBB SYSTEM
• Applicant: Synthes
• Product Code: NDN · Orthopedic
• Decision Date: Dec 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vertebral Body 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

Synthes VBB System is a vertebral augmentation device consisting of a balloon catheter, inflation system, and access kit. Used in clinical settings by physicians for percutaneous vertebral augmentation. The balloon catheter, featuring a stainless steel radiographic marker, is inserted into the vertebral body; the inflation system expands the balloon to reduce fractures or create a void in cancellous bone. Following void creation, the balloon is removed and the cavity is filled with cleared PMMA bone cement. The device assists in restoring vertebral height and stabilizing fractures, potentially reducing pain and improving patient outcomes. Operation is manual, guided by radiographic imaging.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench and biomechanical testing, including balloon pressure, volume limitations, burst characteristics, and system usability assessments.

Technological Characteristics

System includes a vertebral body balloon catheter with an inflatable distal component and stainless steel radiographic marker (ISO 5832-1). Operates via manual inflation system. Designed for use with cleared spinal PMMA bone cements. Mechanical/biomechanical testing performed to verify performance against established acceptance criteria.

Indications for Use

Indicated for patients requiring reduction of spinal fractures or creation of a void in cancellous bone during percutaneous vertebral augmentation procedures (e.g., kyphoplasty). Used in conjunction with cleared spinal 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

• CareFusion Avamax (K093463)
• Kyphon KyphX Xpander Inflatable Bone Tamp (K041454)
• Stryker iVAS (K093419)
• Cardinal Health Inflatable Bone Tamp (K090211)
• Boston Scientific Sterling Monorail PTA Balloon Dilatation Catheters (K053118, K080982)
• Synthes Click'X (K992739)

Submission Summary (Full Text)

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K11.06.04

DEC 1 3 2011-2

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### 5 510(k) Summary

| Name of Firm: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Jason Lipman<br>Manager, Spine Regulatory Affairs<br>Telephone: [phone] Facsimile: 610-719-5102<br>Email: [e-mail] |
| Date Prepared: | March 1, 2011 |
| Trade Name: | Synthes VBB System |
| Classification: | 21 CFR 888.3027 - Cement, Bone, Vertebroplasty<br>Class II<br>Orthopaedic and Rehabilitation Devices Panel<br>Product Code: NDN, HRX |
| Predicate Devices: | CareFusion Avamax (K093463)<br>Kyphon KyphX Xpander Inflatable Bone Tamp (K041454)<br>Stryker iVAS (K093419)<br>Cardinal Health Inflatable Bone Tamp (K090211)<br>Boston Scientific Sterling Monorail PTA Balloon Dilatation Catheters (K053118, K080982)<br>Synthes Click'X (K992739) |
| Device Description: | The VBB System consists of a Vertebral Body Balloon Catheter,<br>Inflation System, and Vertebral Augmentation Access Kit. The<br>Vertebral Body Balloon Catheter is a bone tamp with an inflatable<br>component (balloon) at the distal end. A stainless steel radiographic<br>marker (ISO 5832-1) is located at the distal tip of the balloon. The<br>balloon is inflated by the Inflation System within the vertebral body. The<br>Vertebral Body Balloon System is intended to be used for the reduction<br>of fractures and/or creation of a void in cancellous bone in the spine.<br>This includes use during percutaneous vertebral augmentation. The<br>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. |
| Intended Use /<br>Indications for Use: | The Vertebral Body 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. |
| 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 VBB<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 | Mechanical and biomechanical testing was performed in order to<br>provide data to support a substantial equivalence determination. These |
| Clinical) | tests were performed to characterize the properties and functionality of<br>the VBB 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, system usability, and ability of the device to be used for<br>the reduction of fractures and/or creation of a void in cancellous bone.<br>The conclusions drawn from testing demonstrate that the VBB System is<br>as safe and effective as the predicate devices identified. Clinical data<br>was not needed for this device. |

Traditional 510(k) - Synthes Vertebral Body Balloon (VBB) System

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## @ SYNTHES® Spine

Traditional 510(k) - Synthes Vertebral Body Balloon (VBB) System

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

DEC 1 3 2011

Synthes Spine % Mr. Jason Lipman Manager, Spine Regulatory Affairs 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: - K110604

Trade/Device Name: Synthes VBB System Regulation Number: 21 CFR 888,3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: December 07, 2011 Received: December 08, 2011

Dear Mr. Lipman:

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

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Page 2 - Mr. Jason Lipman

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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely, yours,

Evin S. Keith

Fr 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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#### 4 Indications for Use Statement

510(k) Number: Device Name: Synthes VBB System

Indications for Use:

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

Prescription Use X AND / OR Over-the-Counter Use (21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K 110604 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Traditional 510(k) - Synthes Vertebral Body Balloon (VBB) System