VERTEBROPLASTIC RADIOPAQUE BONE CEMENT

K043406 · Depuy Spine, Inc. · NDN · Jul 15, 2005 · Orthopedic

Device Facts

• Record ID: K043406
• Device Name: VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
• Applicant: Depuy Spine, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Jul 15, 2005
• Decision: SESE
• Submission Type: Traditional
• 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; used for filling spinal vertebral body defects to provide stabilization and pain relief. Device features low viscosity and extended working/setting time. Intended for use by physicians in clinical settings during vertebroplasty or kyphoplasty procedures. The cement is injected into the vertebral body to stabilize fractures caused by osteoporosis or lesions. Benefits include structural support and pain reduction for patients with vertebral fractures.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing of physical and chemical properties.

Technological Characteristics

Self-curing PMMA bone cement; radiopaque; low viscosity; extended working and setting time. Material is a standard acrylic bone cement formulation.

Indications for Use

Indicated for patients with pathological vertebral body fractures due to osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancer, 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

• KyphX® HV-R™ Bone Cement Model C01A (K041584)
• Stryker SpinePlex™ Radiopaque Bone Cement (K032945)
• Stryker Howmedica Surgical Simplex® P Radiopaque pre-packed in ACM and MixEvac II (K002652)
• Cranioplastic™, acrylic cranioplasty material (K873689)

Submission Summary (Full Text)

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K043406

## PREMARKET NOTIFICATION [510(k)] SUMMARY

| Trade Name: | Vertebroplastic™ Radiopaque Bone Cement | JUL 1 5 2005 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Common Name: | Polymethylmethacrylate (PMMA) bone cement | |
| Classification Name: | Filler bone cement (for vertebroplasty) | |
| Regulatory Class: | Class II, per 21 CFR §888.3027, | |
| Device Code: | NDN | |
| 510k Sponser: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, Massachusetts 02767-0350 | |
| Manufacturer: | DePuy International Limited, trading as<br>DePuy CMW<br>Cornford Road<br>Blackpool<br>Lancashire FY4 4QQ<br>United Kingdom | |
| Contact Person: | Sharon Starowicz,<br>Director of Regulatory Affairs<br>DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, Massachusetts 02767-0350<br>Tel.: [phone]; Fax: [phone] | |
| Equivalent to: | KyphX® HV-R™ Bone Cement Model C01A (K041584)<br>Stryker SpinePlex™ Radiopaque Bone Cement (K032945)<br>Stryker Howmedica Surgical Simplex® P Radiopaque pre-packed in<br>ACM and MixEvac II (K002652)<br>Cranioplastic™, acrylic cranioplasty material (K873689) | |
| Device Description: | Vertebroplastic™ Radiopaque Bone Cement is a self-curing,<br>radiopaque, polymethylmethacrylate (PMMA) cement, for filling of<br>spinal vertebral body defects, in order to provide stabilization of the<br>vertebral body and pain relief. Vertebroplastic™ Radiopaque Bone<br>Cement has a low viscosity and long working and setting time | |

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sharon Starowicz Director of Regulatory Affairs . DePuv Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350 JUL 1 5 2005

Re: K043406

Trade Name: Vertebroplastic Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Bone Cement for Vertebroplasty Regulatory Class: II Product Code: NDN Dated: June 8, 2005 Received: June 9, 2005

Dear Ms. Starowicz:

We have reviewed your Section 510(k) premarket notification of intent to market the device in diedicati We have reviewed your Section 910(x) promatice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regarry manation povice Amendments, or to commerce prof to May 26, 1776, the encenters with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of actived a devices that have been recuired in acceraaned while hall has aremarket approval application (PMA). and Cosment Act (Act) that to not require approval controls provisions of the Act. The You may, therefore, market the device, basject to the securements for annual registration, listing of general controls provisions of the Act moration requirement misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in can If your device is classified (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entroller of Color Sep. In addition, FDA may be found in the Code of Peachartergaming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated on a badevice complies with other requirements of the Act that FDA has made a determination that your star formistered by other Federal agencies. You must of any Federal Statutes and regulations animations or system on and listing (21 comply with an the Act s requirements, mercums, can and acturing practice requirements as set

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Page 2 - Sharon Starowicz

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. 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrb/industry/support/index.html>.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

## Device Name: Vertebroplastic™ Radiopaque Bone Cement

Indications for 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).

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Evelin

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

51001, Monitor K043426

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