KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set

K152604 · Medtronic Sofamor Danek USA, Incorporated · PML · Jan 6, 2016 · Orthopedic

Device Facts

• Record ID: K152604
• Device Name: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
• Applicant: Medtronic Sofamor Danek USA, Incorporated
• Product Code: PML · Orthopedic
• Decision Date: Jan 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

Device Story

System comprises high-viscosity, radiopaque, self-curing PMMA bone cement and cannulated multi-axial fenestrated screws; used in thoracic and lumbar spine. Physician mixes powder (methylmethacrylate-styrene co-polymer, barium sulfate, di-benzoyl peroxide) and liquid (methylmethacrylate monomer, N, N dimethyl-p-toluidine, hydroquinone) to create homogenous paste. Cement injected through screw fenestrations into targeted vertebral body to provide fixation and restore spinal integrity in tumor patients. Screws connect to standard spinal rods. Procedure performed by surgeons in clinical/OR setting. Output is stabilized spinal segment; aids clinical decision-making by providing temporary structural support where fusion is not feasible; benefits patients by addressing spinal instability caused by metastatic disease.

Clinical Evidence

Clinical and non-clinical performance data provided in support of substantial equivalence. No specific clinical study metrics (e.g., sensitivity, AUC) are detailed in the summary.

Technological Characteristics

PMMA-based bone cement (powder/liquid components); cannulated multi-axial screws with six distal fenestrations; diameters 4.5mm-10.5mm; lengths 30-100mm. Materials: PMMA, methylmethacrylate-styrene co-polymer, barium sulfate, methylmethacrylate monomer. Mechanical fixation via cement augmentation. Non-sterile screws; sterile cement components.

Indications for Use

Indicated for patients with advanced stage tumors of the thoracic and lumbar spine where life expectancy is insufficient for fusion and spinal structural integrity is not severely compromised.

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)
• CD HORIZON® Spinal System (K042025)
• CD HORIZON® Spinal System (K113174)

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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.

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

January 6, 2016

Medtronic Sofamor Danek USA, Incorporated Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis, Tennessee 38132

Re: K152604

Trade/Device Name: KYPHON HV-R® Fenestrated Screw Cement, CD HORIZON® Fenestrated Screw Set Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: PML, MNI Dated: December 8, 2015 Received: December 9, 2015

Dear Mr. Grant:

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

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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" (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 yours,

# Lori A. Wiggins -S

for 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) K152604

Device Name KYPHON HV-R® Fenestrated Screw Cement

Indications for Use (Describe)

When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw Coment is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

| 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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### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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## Indications for Use

510(k) Number (if known) K152604

Device Name CD HORIZON® Fenestrated Screw Set

### Indications for Use (Describe)

When used in conjunction with KYPHON HV-R® Fenestrated Screw Cement, the CD HORIZON® Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in of insufficient duration to permit achievement of fusion. CD HORIZON® Fenestrated Screws augmented with KYPHON HV-R® Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Type of Use (*Select one or both, as applicable*)

| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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### 510(k) Summary – K152604

# Medtronic Sofamor Danek USA, Inc.

### December 2015

| Submitter | Medtronic Sofamor Danek USA, Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: [phone]<br>Fax: [phone] |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact(s) | Lee Grant<br>Distinguished Regulatory Affairs Advisor<br>Direct Telephone – 901-344-0807<br><br>Pamela Edwards<br>Principal Regulatory Affairs Specialist<br>Direct Telephone -901-399-2125 |
| Date Prepared | December 30, 2015 |
| Trade Name | 1) KYPHON HV-R® Fenestrated Screw Cement<br>2) CD HORIZON® Fenestrated Screw Set |
| Regulatory Class | 1) KYPHON HV-R® Fenestrated Screw Cement<br>Class II |
| Regulation Number | 888.3027 Polymethylmethacrylate (PMMA) Bone Cement<br>PML |
| Regulation Name and Device<br>Product Classification Code | 2) CD HORIZON® Fenestrated Screw Set<br>Class II<br>21 CFR 888.3070 Pedicle Screw System<br>MNI |
| Predicate Devices | 1) KYPHON® HV-R® Bone Cement (Primary Predicate)<br>K150460 KYPHON® HV-R® Bone Cement (SE 04/28/15)<br><br>2) CD HORIZON® Spinal System<br>K042025 CD HORIZON® Spinal System (SE 08/25/04) and<br>K113174 CD HORIZON® Spinal System (SE 11/21/11) |
| | The predicate devices have not been subject to a design related recall |
| Description of Device | 1) KYPHON HV-R® Fenestrated Screw Cement is self-curing PMMA<br>based (high viscosity, radiopaque) bone cement. KYPHON HV-R®<br>Fenestrated Screw Cement will be provided sterile in two components:<br>20 grams of powder and nine grams of liquid. The powder contains<br>methylmethacrylate-styrene co-polymer, barium sulfate as a<br>radiopacifier, and di-benzoyl peroxide as an initiator. This liquid<br>contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a<br>promoter and hydroquinone as a stabilizer. The powder and liquid |
| | components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer. |
| | 2) The CD HORIZON® Fenestrated Screw Set consists of a variety of cannulated multi-axial screws (MAS) with fenestrations offered in diameters ranging from 4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD HORIZON® LEGACY™ and CD HORIZON® SOLERA™ implants contained in the CD HORIZON® Spinal System. The CD HORIZON® Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the CD HORIZON® Spinal System. The screws contain six fenestrations near the distal tip of the screw which provides a controlled means to deliver a small amount of polymethylmethacrylate (PMMA) bone cement into a targeted vertebral body. These screws are provided non-sterile. |
| Indications for Use: | 1) KYPHON HV-R® Fenestrated Screw Cement: When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised. |
| | 2) CD HORIZON® Fenestrated Screw Set: When used in conjunction with KYPHON® HV-R Fenestrated Screw Cement, the CD HORIZON® Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON® Fenestrated Screws augmented with KYPHON HV-R® Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. |
| Comparison of Technological<br>Characteristics with the<br>Predicate Devices | 1) The KYPHON® HV-R® Fenestrated Screw Cement is identical in composition, method of manufacture and sterilization to the primary predicate Kyphon® H-VR® Bone Cement cleared by the FDA in K150460 (SE 04/28/15). The predicate cement is intended to be used in patients diagnosed with pathological fractures in the vertebral body caused by conditions such as osteoporosis and cancer. The subject cement is also intended to be used in patients with metastatic cancer. Pathological fractures reflect one means in which spinal instability occurs and therefore in both instances the predicate and subject cement are intended to treat spinal instability. The only differences between the subject and predicate cement are the method in which the cement is delivered and that the subject cement is limited to patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of |
| | fusion. |
| | 2) The screws which comprise the CD HORIZON® Fenestrated Screw Set<br>have the same or similar indications, intended use, fundamental<br>scientific technology, and are manufactured from similar materials as the<br>pedicle screws found in the following FDA cleared CD HORIZON®<br>Spinal System applications: K042025 (SE 08/25/2004) and K113174<br>(SE 11/21/2011). The predicate screws in this application are cleared for<br>pedicle fixation in patients with spinal instability caused by tumors. The<br>subject pedicle screws are also intended to provide pedicle fixation in<br>patients diagnosed with spinal instability caused by tumors. Both the<br>predicate and subject screws are cannulated, are manufactured from the<br>same material, are similar in design, sizes and are intended to be used<br>with the same spinal rods and connecting components. The primary<br>difference is the subject screws contain fenestrations which allow<br>PMMA cement to flow in a controlled manner through the screw and<br>into the targeted pedicle. |
| Performance Data | Clinical data and Non-Clinical testing were provided in support of substantial<br>equivalence of the subject device. |
| Conclusion | Based on the provided performance data, the subject KYPHON® HV-R<br>Fenestrated Screw Cement is substantially equivalent to the KYPHON® HV-R®<br>Bone Cement (K150460, SE 04/28/15) and the CD HORIZON® Fenestrated<br>Screw Set is substantially equivalent to the CD HORIZON® Spinal System<br>(K042025 (SE 08/25/2004) and K113174 (SE 11/21/2011)). |

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