Kyphon HV-R Bone Cement

K160983 · Medtronic, Inc. · NDN · Aug 24, 2016 · Orthopedic

Device Facts

• Record ID: K160983
• Device Name: Kyphon HV-R Bone Cement
• Applicant: Medtronic, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Aug 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Kyphon® HV-R® 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. Cancer includes multiple myeloma and metastatic lesions. including those arising from breast 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

Two-component PMMA bone cement system; powder (PMMA copolymer, barium sulfate radiopacifier, benzoyl peroxide initiator) and liquid (methylmethacrylate monomer, hydroquinone stabilizer, N,N-dimethyl-p-toluidine promoter) mixed prior to use. Used by physicians in clinical settings during kyphoplasty or vertebroplasty procedures to stabilize vertebral fractures. Provides structural reinforcement to the vertebral body; benefits patients by reducing pain and restoring vertebral integrity.

Clinical Evidence

No clinical data. Substantial equivalence based on technological characteristics, chemical composition, and performance testing.

Technological Characteristics

Two-component PMMA bone cement. Powder: PMMA copolymer, barium sulfate, benzoyl peroxide. Liquid: methylmethacrylate monomer, hydroquinone, N,N-dimethyl-p-toluidine. Sterilization and bacterial endotoxin testing (20 EU/mL limit, gel clot method) consistent with predicates.

Indications for Use

Indicated for treatment of pathological vertebral body fractures due to osteoporosis, cancer (multiple myeloma, metastatic lesions from breast/lung/lymphoma), or benign lesions (hemangioma, giant cell tumor) via cementoplasty. 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® HV-R® Bone Cement (K150460)
• KYPHON® Xpede™ Bone Cement (K151227)

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

August 24, 2016

Re: K160983

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: August 1, 2016 Received: August 2, 2016

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 Parts 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.

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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/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 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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K160983

Device Name Kyphon® HV-R® Bone Cement

#### Indications for Use (Describe)

Kyphon® HV-R® 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. Cancer includes multiple myeloma and metastatic lesions. including those arising from breast 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)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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FORM FDA 3881 (8/14)

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### 510(k) Summary Medtronic Sofamor Danek

# KYPHON® HV-R® Bone Cement

# August 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] |
| Date Prepared | March 2016 |
| Common Name | KYPHON® HV-R® 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 | KYPHON® HV-R® Bone Cement |
| | K150460, S.E. 04/28/2015 (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® HV-R® 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® HV-R™ 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. 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. |

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| Comparison of Technological<br>Characteristics with the<br>Predicate Devices | The subject KYPHON® HV-R® Bone Cement has the same fundamental<br>scientific technology as the predicates KYPHON® HV-R® Bone Cement<br>(K150460 S.E. 4/28/2015) and KYPHON® Xpede™ Bone Cement (K151227<br>S.E. 11/16/2015). The subject device utilizes equivalent implant materials,<br>sterilization methods and bacterial endotoxin testing applying the same 20<br>EU/mL pyrogen limit specifications utilizing the gel clot test method as the<br>predicates KYPHON® HV-R® Bone Cement (K150460 S.E. 4/28/2015) and<br>KYPHON® Xpede™ Bone Cement (K151227 S.E. 11/16/2015). |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The design features, device materials, chemical composition, device<br>performance, packaging of the device materials, manufacturing and sterilization<br>methods are substantially equivalent to the previously cleared KYPHON® HV-<br>R® Bone Cement (K150460 S.E. 4/28/2015) and KYPHON® Xpede™ Bone<br>Cement (K151227 S.E. 11/16/2015). The updated indication does not raise new<br>issues of safety or effectiveness. The intended use for KYPHON® HV-R®<br>Bone Cement has not changed and is identical to the predicates KYPHON® HV-<br>R® Bone Cement (K150460 S.E. 4/28/2015) and KYPHON® Xpede™ Bone<br>Cement (K151227 S.E. 11/16/2015). |