MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT

K071927 · Depuy Spine, A Johnson & Johnson Company · NDN · Nov 21, 2007 · Orthopedic

Device Facts

• Record ID: K071927
• Device Name: MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
• Applicant: Depuy Spine, A Johnson & Johnson Company
• Product Code: NDN · Orthopedic
• Decision Date: Nov 21, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Device Story

Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque PMMA bone cement. It is used to fill spinal vertebral body defects resulting from compression fractures to provide stabilization and pain relief. The device is intended for use by clinicians during vertebroplasty or kyphoplasty procedures. The modification involves a change to the formulation of the liquid component of the bone cement.

Technological Characteristics

Self-curing, radiopaque polymethylmethacrylate (PMMA) bone cement. Class II device (21 CFR 888.3027).

Indications for Use

Indicated for patients with pathological vertebral body fractures due to 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

• Vertebroplastic™ Radiopaque Bone Cement (K043406)
• SmartSet GMV Endurance Gentamicin Bone Cement (K033382)

Submission Summary (Full Text)

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K071927.

# 000004

## SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham<br>MA 02767-0350 | | NOV 21 2007 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------|--|-------------|
| 510(k) CONTACT: | Sharon Starowicz<br>Director of Regulatory Affairs | | |
| TRADE NAME: | Vertebroplastic™ Radiopaque Bone Cement | | |
| COMMON NAME: | Polymethyl Methacrylate (PMMA) Bone Cement | | |
| CLASSIFICATION: | Class II; 21 CFR 888.3027 | | |
| DEVICE PRODUCT CODE: | NDN | | |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | Vertebroplastic™ Radiopaque Bone Cement (K043406)<br>SmartSet GMV Endurance Gentamicin Bone Cement<br>(K033382). | | |

#### DEVICE DESCRIPTION:

Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) cement, for filling of spinal vertebral body defects resulting from compression fracture, in order to provide stabilization of the collapsed vertebral body and pain relief. The following modifications are being made:

Change to the formulation of the bone cement liquid component.

#### INTENDED USE AND INDICATIONS:

Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

### BASIS OF SUBSTANTIAL EQUIVALENCE:

The substantial equivalence of modified Vertebroplastic™ Radiopaque Bone Cement to the identified predicate devices is demonstrated by its similarity in terms of technological characteristics (chemical composition, material properties, performance characteristics, manufacture, packaging and sterilization) to the Vertebroplastic ™ Radiopaque Bone Cement manufacture, packaging and stermization) is no verconton - Trackepages - President - Premientalized by institution (K1043406) and SmartSet GMT Endirance Geneament Boller (Called (Called (CNS 0) Start
similarity in terms of intended use and indications for use to the Vertebroplastic ™ Radi Bonc Cement (K043406).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2007

Depuy Spine, Inc. % Ms. Sharon Starowicz Director of Regulatory Affairs 325 Paramount Drive Raynham, MA 02767-0350

Re: K071927

Trade/Device Name: Vertebroplastic™ Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Names: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, LOD Dated: November 1, 2007 Received: November 2, 2007

Dear Ms. Starowicz:

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 such 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); 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 - Ms. Sharon Starowicz

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Millerson

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

Enclosure

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# 000005

## Indications for Use Statement

510(k) Number (if known):

Device Name: Vertebroplastic™ Radiopaque Bone Cement

Indications for Use:

The Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, my elama),

Prescription Use X (Part 21 CFR 801.Subpart D) OR

Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Houbare Bonem

(Division Sign-Off) (Division Sign of General, Restorative, Division Neurological Devices

**510(k) Number** K071927

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