Kyphon Xpede Bone Cement

K163032 · Medtronic, Inc. · NDN · Feb 27, 2017 · Orthopedic

Device Facts

• Record ID: K163032
• Device Name: Kyphon Xpede Bone Cement
• Applicant: Medtronic, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Feb 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

Device Story

Kyphon® Xpede™ Bone Cement is a two-component PMMA system; powder (PMMA copolymer, barium sulfate, benzoyl peroxide) and liquid (methylmethacrylate monomer, hydroquinone, N,N-dimethyl-p-toluidine) are mixed prior to use. Used by physicians in clinical settings for cementoplasty (kyphoplasty/vertebroplasty) or sacral procedures (sacroplasty). The cement provides structural fixation for pathological fractures. Clinical benefit includes stabilization of fractures and pain management. Procedure involves imaging-guided delivery to minimize extravasation risk.

Clinical Evidence

Retrospective clinical literature review of 462 patients across five articles demonstrated safety and efficacy of PMMA bone cement for sacral vertebroplasty/sacroplasty. Cadaver study evaluated cement extravasation behavior using long-axis and short-axis surgical techniques; extravasation rates were within the range reported in published sacroplasty literature.

Technological Characteristics

Two-component PMMA bone cement. Powder: PMMA copolymer, barium sulfate (radiopacifier), benzoyl peroxide (initiator). Liquid: methylmethacrylate monomer, hydroquinone (stabilizer), N,N-dimethyl-p-toluidine (promoter). Sterilization and bacterial endotoxin testing (gel clot method, 20 EU/ml limit) match predicate.

Indications for Use

Indicated for patients with pathological vertebral body fractures due to osteoporosis, cancer (multiple myeloma, metastatic breast/lung cancer, lymphoma), or benign lesions (hemangioma, giant cell tumor). Also indicated for fixation of pathological sacral vertebral body or ala fractures via sacral vertebroplasty or sacroplasty. Includes symptomatic microfractures without height loss.

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

• Vertaplex® High Viscosity (HV) Radiopaque Bone Cement (K150582)
• Kyphon® Xpede™ Bone Cement (K151227)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other.

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

February 27, 2017

Medtronic Inc. Ms. Pamela Edwards Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132

Re: K163032

Trade/Device Name: Kyphon® Xpede " Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: January 27, 2017 Received: January 30, 2017

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 devicerelated 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.

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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" (21 CFR 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.

Sincerely.

Mark N. Melkerson -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

# Indications for Use

510(k) Number (if known)

### K163032

Device Name Kyphon® Xpede™ Bone Cement

#### Indications for Use (Describe)

Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">❌</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span style="font-size:16px">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## 510(k) Summary Medtronic Sofamor Danek USA, Inc.

# October 21, 2016

| Submitter | Medtronic Sofamor Danek USA, Inc. |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1800 Pyramid Place |
| | Memphis, Tennessee 38132 |
| | Telephone: [phone] |
| | Fax: [phone] |
| Contact | Pamela Edwards |
| | Principal Regulatory Affairs Specialist |
| | Direct Telephone: [phone] |
| | Jeff Sprague |
| | Sr. Regulatory Affairs Program Manager |
| | Direct Telephone: [phone] |
| Date Prepared | October 21, 2016 |
| Common Name | Kyphon® Xpede™ Bone Cement |
| Regulatory Class | Class II |
| Regulation Number | 21 CFR 888.3027 |
| Regulation Name and Device | Polymethylmethacrylate (PMMA) bone cement |
| Product Classification Code | NDN |
| Predicate Devices | Vertaplex® High Viscosity (HV) Radiopaque Bone Cement |
| | K150582, S.E. 06/12/2015 (Primary Predicate) |
| | Kyphon® Xpede™ Bone Cement |
| | K151227, S.E. 11/16/2015 |
| | The predicate devices have not been subject to a design related recall. |
| Description of Device | Kyphon® Xpede™ Bone Cement is provided as a two component system. The |
| | powder component consists of a PMMA copolymer (polymethylmethacrylate/ |
| | methyl-methacrylate-styrene copolymer) with barium sulfate as a radiopacifier |
| | and benzoyl peroxide as an initiator. The liquid component consists of |
| | methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer |
| | and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid |
| | components are mixed prior to use. |
| Indications for Use: | Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological |
| | fractures of the vertebral body due to osteoporosis, cancer, or benign lesions<br>using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also<br>indicated for the fixation of pathological fractures of the sacral vertebral body or<br>ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma<br>and metastatic lesions, including those arising from breast or lung cancer, or<br>lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic<br>fracture may include a symptomatic vertebral body microfracture (as<br>documented by appropriate imaging and/or presence of a lytic lesion) without<br>obvious loss of vertebral body height. |
| Comparison of<br>Technological<br>Characteristics<br>with<br>the | The subject Kyphon® Xpede™ Bone Cement has the same or similar indications<br>for use, intended use, materials and fundamental scientific technology as the |
| Predicate Devices | predicates Vertaplex® High Viscosity (HV) Radiopaque Bone Cement |
| | (K150582, S.E. 06/12/2015) and Kyphon® Xpede™ Bone Cement (K151227, |
| | S.E. 11/16/2015). The subject device utilizes equivalent implant materials,<br>sterilization methods and bacterial endotoxin testing applying the same 20 |
| | EU/ml pyrogen limit specifications utilizing the gel clot test method as the |
| | predicate Kyphon® Xpede™ Bone Cement (K151227, S.E. 11/16/2015). |
| Performance Data | Clinical literature data and cadaveric testing was provided to support the |
| | substantial equivalence of the subject device. |
| | A retrospective clinical literature review was performed to examine the potential<br>benefits and associated risks of using PMMA bone cement using a sacral<br>vertebroplasty or sacroplasty procedure. The five articles reviewed provided<br>clinical outcomes of 462 patients utilizing both the long-axis and short-axis<br>surgical technique demonstrating the safety and efficacy of PMMA bone cement<br>when used in the sacrum. |
| | A cadaver study in support of the expanded indication was completed. This<br>study was performed to evaluate the extravasation behavior of the Kyphon®<br>Xpede™ Bone Cement during sacroplasty procedures. The study also defined<br>the surgical procedure steps and imaging needed to minimize the risk of<br>extravasation for the sacroplasty procedure. Both the long-axis and short-axis<br>surgical techniques were evaluated for cement extravasation. The procedure and<br>imaging review was performed by trained physicians. The calculated<br>extravasation rate with the Kyphon® Xpede™ Bone Cement was within the<br>extravasation rate range of the published sacroplasty literature. |
| Conclusion | Based on the provided performance data, the subject Kyphon® Xpede™ Bone |
| | Cement is substantially equivalent to the primary predicate Vertaplex® High<br>Viscosity (HV) Radiopaque Bone Cement (K150582, S.E. 06/12/2015) and |
| | Kyphon® Xpede™ Bone Cement (K151227, S.E. 11/16/2015). |

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