STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)

K090986 · Dfine, Inc. · NDN · Dec 30, 2009 · Orthopedic

Device Facts

• Record ID: K090986
• Device Name: STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)
• Applicant: Dfine, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Dec 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

StabiliT ER Bone Cement: The StabiliT ER Bone Cement is intended for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement) The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ER Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Story

StabiliT ER Bone Cement is a two-component PMMA bone cement. StabiliT Vertebral Augmentation System is a motorized, microprocessor-controlled delivery device for percutaneous injection of the cement during vertebroplasty or kyphoplasty. The system features integrated cement warming capabilities during delivery. Used in clinical settings by physicians to treat vertebral fractures. The system provides controlled delivery of cement to the vertebral body; the physician monitors the procedure to stabilize the fracture and alleviate pain. Benefits include improved procedural control and cement handling.

Clinical Evidence

Bench testing only. In-vitro testing (material, performance, mechanical, electrical) confirmed the system functions as intended. Biocompatibility testing meets ISO 10993-1 requirements.

Technological Characteristics

Two-component PMMA bone cement. Motorized, microprocessor-controlled delivery system. Features cement warming during delivery. Biocompatible materials per ISO 10993-1.

Indications for Use

Indicated for patients with painful vertebral compression fractures resulting from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma) requiring vertebroplasty or kyphoplasty.

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

• StabiliT ER Bone Cement (formerly SPACE CpsXL Bone Cement) (K072496)
• SPACE 360 Delivery System (StabiliT Vertebral Augmentation System) (K070351)

Submission Summary (Full Text)

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#### 510(K) SUMMARY OR 510(K) STATEMENT ട.

K090986

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: 04/06/09

510(k) number: __

ﺎ

### Applicant Information:

DFine Inc. 3047 Orchard Parkway San Jose, CA 95134, USA

# Contact Person

| Sandeep Saboo | |
|---------------|-----------------------|
| Phone Number: | 408-321-9999 ext 248 |
| Fax Number: | 408-321-9401 |
| e-mail: | [e-mail] |

### Device Information:

| Trade Name: | StabiliT ER* Bone Cement |
|----------------------|--------------------------------------------------|
| | StabiliT Vertebral Augmentation System |
| Classification: | Class II (StabiliT ER* Bone Cement) |
| | Class I (StabiliT Vertebral Augmentation System) |
| Classification Name: | Bone Cement |
| | Cement Dispenser |

### Physical Description:

StabiliT ER* Bone Cement

The StabiliT ER Bone Cement is two-component PMMA bone cement with a powder component and a liquid component.

StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement)

StabiliT Vertebral Augmentation System is a motorized, microprocessor controlled bone cement delivery system intended for percutaneous delivery of bone cement in vertebroplasty or kyphoplasty procedures that allows for warming of the cement during cement delivery.

### Intended Use:

# StabiliT ERA Bone Cement

The StabiliT ER Bone Cement is intended for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement) The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ER Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment

DFine Inc.

DEC 30 2009

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of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

#### Test Results:

### Performance

Results of in-vitro testing (material, performance, mechanical, electrical) demonstrate that the StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) functioned as intended and the results of tests were as expected.

#### Biocompatibility

The materials used in the StabiliT ER' Bone Cement and StabiliT Vertebral Augmentation System (StabiliT ERA Bone Cement) meet the requirements of ISO 10993-1.

#### Substantial Equivalence and Summary:

The subject devices StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement) have the same intended use and indications, technological characteristics and principles of operation as their predicate, respectively, StabiliT ER Bone Cement (formerly known as SPACE CpsXL Bone Cement) [K072496] and SPACE 360 Delivery System (for use with SPACE CpsXL Bone Cement) [K070351] (also called StabiliT Vertebral Augmentation System).

The minor technological differences between StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) and their predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that StabiliT ER Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) are as safe and effective as the predicate devices for their intended use. Thus, StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement) are substantially equivalent to their marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three faces in profile, suggesting a sense of community and diversity. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DFine Inc. % Mr. Sandeep Saboo 3047 Orchard Parkway San Jose, California 95134

DEC 30 2009

Re: K090986

Trade/Device Name: StabiliT ER Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) Regulation Number: 21 CFR 888.3027 Regulation Name: Polmethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, KIH Dated: December 17, 2009 Received: December 18, 2009

Dear Mr. Saboo:

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.

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 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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# Page 2 – Mr. Sandeep Saboo

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Daniel Kane

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

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K090986

Device Name: StabiliT ERX Bone Cement and

StabiliT Vertebral Augmentation System (for use with StabiliT ERX Bone Cement)

Indications for Use:

# StabiliT ER Bone Cement:

The StabiliT ER Bone Cement is intended for the treatment of pathological fractures He Stablin E. ( Bertebroplasty or kyphoplasty procedure. Painful vertebral of the vertobrato acing a vertosit from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

# StabiliT Vertebral Augmentation System (for use with StabiliT ER * Bone Cement):

Ochienty.
The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of The Otablir? Vortobrament in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression treathent of pathologiod fractaros onish benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of GDRH, Offjge of Device Evaluation (ODE)

RANDALL R. ARNOLD FOR M.MEUKERSON

Page _ of _

Division of Surgical, Orthopedic, and Restorative Devices

(Division Sign-Off)

K090986

DFine Inc.

Response to Deficiency Questions - K090986 Stork) Number StabiliT ER Bone Cement, and StabiliT Vertebral Augmentation System for use with StabiliT ER* Bone Cement Page 37