KYPHON HV-R Bone Cement

K180700 · Medtronic Sofamor Danek USA, Inc. · NDN · May 18, 2018 · Orthopedic

Device Facts

• Record ID: K180700
• Device Name: KYPHON HV-R Bone Cement
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: May 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KYPHON™ HV-RTM Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty 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. Pathological 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

Two-component PMMA bone cement system; powder (PMMA copolymer, barium sulfate, benzoyl peroxide) and liquid (methylmethacrylate monomer, hydroquinone, N,N-dimethyl-p-toluidine) mixed prior to use. Used by physicians in clinical settings for cementoplasty, vertebroplasty, or sacroplasty procedures. Provides structural fixation for pathological fractures. Benefits include stabilization of vertebral/sacral fractures, potentially reducing pain and restoring structural integrity. Clinical decision-making guided by imaging (e.g., identifying lytic lesions or microfractures).

Clinical Evidence

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

Technological Characteristics

Two-component PMMA bone cement. Powder: PMMA/methyl-methacrylate-styrene copolymer, barium sulfate (radiopacifier), benzoyl peroxide (initiator). Liquid: methylmethacrylate monomer, hydroquinone (stabilizer), N,N-dimethyl-p-toluidine (promoter). Bacterial endotoxin limit: 20 EU/ml (gel clot test).

Indications for Use

Indicated for patients with pathological vertebral body fractures due to osteoporosis, cancer (multiple myeloma, metastatic lesions from breast/lung/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

• Kyphon™ Xpede™ Bone Cement (K163032)
• Kyphon™ HV-R™ Bone Cement (K160983)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue.

May 18, 2018

Medtronic Sofamor Danek USA, Inc. Laveeda Leflore Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132

Re: K180700

Trade/Device Name: KYPHON™ HV-R™ Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: March 15, 2018 Received: March 16, 2018

Dear Ms. Leflore:

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 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);

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K180700

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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: 06/30/2020

See PRA Statement below.

## Indications for Use

510(k) Number (if known)

#### K180700

Device Name KYPHON™ HV-R™ Bone Cement

#### Indications for Use (Describe)

KYPHON™ HV-RTM Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty 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. Pathological 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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

## May 15, 2018

| Submitter | Medtronic Sofamor Danek USA, Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: [phone]<br>Fax: [phone] |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Laveeda Leflore<br>Regulatory Affairs Specialist<br>Direct Telephone: [phone] |
| | Jeff Sprague<br>Sr. Regulatory Affairs Program Manager<br>Direct Telephone: [phone] |
| Date Prepared | May 15, 2018 |
| Common Name | Kyphon™ HV-R™ Bone Cement |
| Regulatory Class | Kyphon™ HV-R™ Bone Cement |
| Regulation Number | Class II |
| Regulation Name and Device | 21 CFR 888.3027 |
| Product Classification Code | Polymethylmethacrylate (PMMA) bone cement<br>NDN |
| Predicate Devices | 1) Kyphon™ Xpede™ Bone Cement K163032, S.E. 02/27/2017 (Primary<br>Predicate) |
| | 2) Kyphon™ HV-R™ Bone Cement K160983, S.E. 08/24/2016 |
| | The predicate devices have not been subject to a design related recall. |
| Description of Device | Kyphon™ HV-R™ Bone Cement is provided as a two-component system.<br>The powder component consists of a PMMA copolymer<br>(polymethylmethacrylate/ methyl-methacrylate-styrene copolymer) with<br>barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The<br>liquid component consists of methylmethacrylate monomer, with the<br>addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as<br>a promoter. The powder and liquid components are mixed prior to use. |
| Indications for Use: | KyphonTM HV-RTM Bone Cement is indicated for the treatment of<br>pathological fractures of the vertebral body due to osteoporosis, cancer, or<br>benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty)<br>procedure. It is also indicated for the fixation of pathological fractures of<br>the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty.<br>Cancer includes multiple myeloma and metastatic lesions, including those<br>arising from breast or lung cancer, or lymphoma. Benign lesions include<br>hemangioma and giant cell tumor. Pathologic fracture may include a<br>symptomatic vertebral body microfracture (as documented by appropriate<br>imaging and/or presence of a lytic lesion) without obvious loss of<br>vertebral body height. |
| Comparison of Technological<br>Characteristics with the<br>Predicate Devices | The subject KyphonTM HV-RTM Bone Cement has the same or similar<br>indications for use, intended use, materials and fundamental scientific<br>technology fundamental scientific technology as the predicates KyphonTM<br>XpedeTM Bone Cement K163032, (S.E. 02/27/2017) and KyphonTM HV-RTM<br>Bone Cement (K160983, S.E. 8/24/2016). The subject device utilizes<br>equivalent implant materials, sterilization methods and bacterial endotoxin<br>testing applying the same 20 EU/ml pyrogen limit specifications utilizing<br>the gel clot test method as the predicate KyphonTM HV-RTM Bone Cement<br>(K160983, S.E. 8/24/2016). |
| Performance Data | Clinical literature data and non-clinical cadaveric testing is provided to<br>support the substantial equivalence of the subject device.<br><br>A retrospective clinical literature review was performed to examine the<br>potential benefits and associated risks of using PMMA bone cement using<br>a sacral vertebroplasty or sacroplasty procedure. The five articles<br>reviewed provided clinical outcomes of 462 patients utilizing both the<br>long-axis and short-axis surgical technique demonstrating the safety and<br>efficacy of PMMA bone cement when used in the sacrum.<br><br>A cadaver study in support of the expanded indication was completed.<br>This study was performed to evaluate the extravasation behavior of the<br>KyphonTM HV-RTM Bone Cement during sacroplasty procedures. The study<br>also defined the surgical procedure steps and imaging needed to minimize<br>the risk of extravasation for the sacroplasty procedure. Both the long-axis<br>and short-axis surgical techniques were evaluated for cement<br>extravasation. The procedure and imaging review was performed by<br>trained physicians. The calculated extravasation rate with the KyphonTM<br>HV-RTM Bone Cement was within the extravasation rate range of the |
| Conclusion | Based on the provided performance data, the subject Kyphon™ HV-R™<br>Bone Cement is substantially equivalent to the primary predicate Kyphon™<br>Xpede™ Bone Cement (K163032, S.E. 02/27/2017) and Kyphon™ HV-R™<br>Bone Cement (K160983, S.E. 08/24/2016). |

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