KYPHON XPEDE Bone Cement

K151227 · Medtronic · NDN · Nov 16, 2015 · Orthopedic

Device Facts

• Record ID: K151227
• Device Name: KYPHON XPEDE Bone Cement
• Applicant: Medtronic
• Product Code: NDN · Orthopedic
• Decision Date: Nov 16, 2015
• 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. 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-based bone cement system; consists of powder (PMMA copolymer, barium sulfate radiopacifier, benzoyl peroxide initiator) and liquid (methylmethacrylate monomer, hydroquinone stabilizer, N,N-dimethyl-p-toluidine promoter). Components mixed by clinician prior to use; injected into vertebral body during cementoplasty, kyphoplasty, or vertebroplasty procedures. Provides structural reinforcement to fractured vertebrae; stabilizes bone; alleviates pain associated with pathological fractures. Used in clinical settings by physicians; output is solidified cement matrix.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance comparison to predicate device.

Technological Characteristics

Two-component PMMA bone cement. Powder: PMMA copolymer, barium sulfate, benzoyl peroxide. Liquid: methylmethacrylate monomer, hydroquinone, N,N-dimethyl-p-toluidine. Radiopaque. Sterilized.

Indications for Use

Indicated for patients with pathological vertebral body fractures due to osteoporosis, cancer (multiple myeloma, metastatic lesions from breast/lung cancer, lymphoma), or benign lesions (hemangioma, giant cell tumor). Includes symptomatic vertebral body microfractures without obvious 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 (K102397)

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. Kathy L. Remsen Senior Regulatory Affairs Program Manager 1800 Pyramid Place Memphis, Tennessee 38132

November 16, 2015

Re: K151227

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: September 28, 2015 Received: October 1, 2015

Dear Ms. Remsen:

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

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forth in the quality systems (OS) 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,

# 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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## Indications for Use

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

510(k) Number (if known) K151227

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 using a cementoplasty or vertebroplasty 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.

| 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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## KYPHON® Xpede™ Bone Cement September 2015

| Company: | Medtronic Sofamor Danek USA, Inc.<br>1800 Pyramid Place<br>Memphis. Tennessee 38132<br>Telephone: [phone]<br>Fax: [phone] |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kathy L. Remsen<br>Senior Regulatory Affairs Program Manager |
| Proprietary Trade Name: | KYPHON® Xpede™ Bone Cement |
| Common Name: | Bone Cement |
| Classification Name: | Cement, bone, vertebroplasty |
| Product Code: | NDN |
| Regulation: | 21 CFR 888.3027 |
| Classification: | II |

### Description:

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

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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.

### Summary of the Technological Characteristics:

The subject Kyphon® Xpede™ Bone Cement has the same fundamental scientific technology as the predicate KYPHON® Xpede™ Bone Cement (K102397 S.E. 2/28/2011). The subject device utilizes equivalent implant materials and sterilization methods.

#### Identification of Legally Marketed Devices:

The subject Kyphon® Xpede™ Bone Cement is substantially equivalent to the predicate Kyphon® Xpede™ Bone Cement (K102397 S.E. 2/28/2011).

#### Conclusion:

The design features, device materials, chemical composition, device performance, packaging of the device materials, manufacturing and sterilization methods are substantially equivalent to the previously cleared Kyphon® Xpede™ Bone Cement (K102397 S.E. 2/28/2011). The revision and modification of the wording in the indications for use do not raise new issues of safety or effectiveness. The indications for use statement for KYPHON® Xpede™ Bone Cement has the same Intended Use as the predicate Kyphon® Xpede™ Bone Cement (K102397 S.E. 2/28/2011).