KYPHON ELEMENT Inflatable Bone Tamp

K151532 · Medtronic, Inc. · HRX · Jul 23, 2015 · Orthopedic

Device Facts

• Record ID: K151532
• Device Name: KYPHON ELEMENT Inflatable Bone Tamp
• Applicant: Medtronic, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jul 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KYPHON ELEMENT™ Inflatable Bone Tamp (IBT) is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during a balloon kyphoplasty procedure with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

Device Story

The KYPHON ELEMENT™ Inflatable Bone Tamp is a manual surgical instrument used for fracture reduction and void creation in cancellous bone. The device consists of a single-lumen shaft, a Y-adapter for connection to an inflation syringe, and an inflatable balloon at the distal tip. Operated by a surgeon in a clinical setting, the device is inserted into the target bone; the balloon is inflated to compress cancellous bone and create a void or reduce a fracture. In spinal applications, it is used in conjunction with cleared PMMA bone cement during kyphoplasty. The device provides a mechanical means to restore bone geometry, potentially reducing pain and stabilizing fractures. It is a single-use, sterile instrument.

Clinical Evidence

Bench testing only. No clinical data provided. Verification activities included mechanical and biocompatibility testing to confirm performance specifications and safety equivalent to the predicate device.

Technological Characteristics

Manual orthopedic surgical instrument. Components: single-lumen shaft, Y-adapter, inflatable distal balloon. Materials equivalent to predicate. Sterilization: standard medical device sterilization. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring fracture reduction or void creation in cancellous bone of the spine, hand, tibia, radius, or calcaneus. Includes use during balloon kyphoplasty with cleared PMMA bone cement.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• KYPHON® XPANDER® Inflatable Bone Tamps (K041454)

Submission Summary (Full Text)

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

Medtronic Sofamor Danek USA, Incorporated Ms. Pamela Edwards Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

July 23, 2015

Re: K151532

Trade/Device Name: KYPHON ELEMENT™ Inflatable Bone Tamp Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HXG Dated: June 9, 2015 Received: June 10, 2015

Dear Ms. Edwards:

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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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

For

Sincerely yours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K151532

Device Name KYPHON ELEMENT™ Inflatable Bone Tamp

Indications for Use (Describe)

The KYPHON ELEMENT™ Inflatable Bone Tamp (IBT) is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during a balloon kyphoplasty procedure with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(K)Summary

| | I. SUBMITTER NAME & ADDRESSS: | Medtronic Sofamor Danek USA, Inc | |
|--|-------------------------------|-----------------------------------------|--|
| | | 1800 Pyramid Place | |
| | | Memphis, Tennessee 38132 | |
| | | Telephone: [phone] | |
| | | Fax: [phone] | |
| | | Establishment Registration: 1030489 | |
| | CONTACT PERSON: | Pamela Edwards | |
| | | Principal Regulatory Affairs Specialist | |
| | DATE PREPARED: | June 5, 2015 | |

- II. PROPOSED PROPRIETARY TRADE NAME: KYPHON ELEMENT™ Inflatable Bone Tamp Arthroscope (21 CFR 888.1100) DEVICE CLASSIFICATION NAME/ Orthopedic Manual Surgical Instrument REGULATION NUMBER: (21 CFR 888.4540) PRODUCT CODE: HRX, HXG CLASSIFICATION: II
## III. IDENTIFICATION OF LEGALLY MARKETED DEVICES:

| Table 1. Legally Marketed Devices | | |
|-------------------------------------------|---------------|------------------------------|
| Device name | 510(k) number | Substantial Equivalence date |
| KYPHON® XPANDER® Inflatable Bone<br>Tamps | K041454 | 07/09/2004 |

## IV. DEVICE DESCRIPTION:

The KYPHON ELEMENT™ Inflatable Bone Tamp is designed for the reduction of fractures. The main components are a single lumen shaft, Y-Adapter with a port to connect the inflation syringe for inflation/deflation, and the inflatable balloon located at the distal tip.

## V. INDICATIONS FOR USE:

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The KYPHON ELEMENT™ Inflatable Bone Tamp (IBT) is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during a balloon kyphoplasty procedure with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

#### VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:

The subject KYPHON ELEMENT™ Inflatable Bone Tamp has the same intended used, fundamental scientific technology, and sterilization as the predicate KYPHON® XPANDER® Inflatable Bone Tamps K041454 (S.E. 07/09/2004). The subject utilizes equivalent basic device design, materials and packaging.

## VII. DISCUSSION OF NON-CLINICAL TESTING:

Assessment of the device modifications have been completed in accordance with Medtronic design control processes. The KYPHON ELEMENT™ Inflatable Bone Tamp has the same design characteristics, packaging, sterilization processes and is made of equivalent materials as the predicate, KYPHON® XPANDER® Inflatable Bone Tamps. Mechanical testing, biocompatibility testing and other verification activities were conducted to confirm that the modified device functions as intended and does not raise any new issues of safety or effectiveness.

#### VIII. CONCLUSION:

Documentation provided in this submission demonstrates that the subject device KYPHON ELEMENT™ Inflatable Bone Tamp is substantially equivalent to the previously cleared KYPHON® XPANDER® Inflatable Bone Tamps K041454 (S.E. 07/09/2004).The subject device is substantially equivalent to predicate in several categories including: intended use, performance specifications and fundamental technological characteristics .