CONCORD Radiopaque Bone Cement

K042168 · Globus Medical, Inc. · NDN · Jan 14, 2005 · Orthopedic

Device Facts

• Record ID: K042168
• Device Name: CONCORD Radiopaque Bone Cement
• Applicant: Globus Medical, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Jan 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Symphony™ VR Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Story

Symphony™ VR Radiopaque Bone Cement is a two-component PMMA bone cement; consists of polymer powder (PMMA copolymer, barium sulfate, benzoyl peroxide) and liquid monomer (methyl methacrylate, hydroquinone, N:N dimethyl-p-toluidine). Used by physicians in clinical settings for vertebroplasty or kyphoplasty procedures to stabilize vertebral compression fractures. The components are mixed to initiate polymerization, creating a radiopaque filler that hardens to provide structural support for fractured vertebral bodies. The radiopacity allows visualization under fluoroscopy during delivery. Benefits include pain relief and stabilization of the vertebral body in patients with fractures due to osteoporosis or lesions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of chemical composition and material properties to predicate devices.

Technological Characteristics

Two-component PMMA bone cement. Powder: PMMA copolymer, barium sulfate (radiopacifier), benzoyl peroxide (initiator). Liquid: Methyl methacrylate monomer, hydroquinone (stabilizer), N:N dimethyl-p-toluidine (activator). Polymerization via chemical reaction. Supplied as sterile components.

Indications for Use

Indicated for fixation of pathological vertebral body fractures via vertebroplasty or kyphoplasty in patients with painful vertebral compression fractures caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

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 (K033801)
• Stryker Spineplex™ Radiopaque Bone Cement (K032945)

Reference Devices

• Howmedica Osteonics Surgical Simplex® P (N017004)

Submission Summary (Full Text)

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## K 042168 7.0 PREMARKET NOTIFICATION 510(K) SUMMARY

| 510(k) Number: | TO BE ASSIGNED | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--|
| Date Prepared: | August 10, 2004 | | |
| Applicant Information: | | | |
| Applicant: | Advanced Biomaterial Systems, Inc.<br>100 Passaic Avenue<br>Chatham, NJ 07928 | | |
| Contact: | John P. Carr<br>Chief Operating Officer | | |
| Telephone:<br>Facsimile: | [phone]<br>[phone] | | |
| Registration: | To be assigned | | |
| Device Information: | | | |
| Trade Name: | Symphony™ VR Radiopaque Bone Cement | | |
| Common Name: | PMMA Bone Cement (For Vertebroplasty) | | |
| Product Code: | NDN | | |
| Classification Name: | Filler, Bone Cement (For Vertebroplasty) | | |
| Regulation Class: | Class II | | |
| Regulation Number: | 21 CFR §888.3027 | | |
| Device Description: | Symphony™ VR Radiopaque Bone Cement is a PMMA bone<br>cement made of the same chemical components as Advanced<br>Biomaterial Systems, Inc. CONCERT® Radiopaque Bone Cement.<br><br>Symphony™ VR Radiopaque Bone Cement is provided as a two-<br>component product. The polymer powder consists of a PMMA<br>copolymer (polymethyl methacrylate and methyl methacrylate-<br>styrene copolymer) with barium sulfate as the radiopacifier and<br>benzoyl peroxide as the initiator. The liquid component consists of<br>methyl methacrylate monomer, which includes hydroquinone as the<br>stabilizer and N:N dimethyl-p-toluidine as the activator. | | |
| Predicate Devices: | K033801: | Kyphon Inc. - KyphX® HV-R Bone Cement | |
| | K032945: | Stryker Spineplex™ Radiopaque Bone Cement | |

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Howmedica Osteonics Surgical Simplex® P N017004: Radiopaque Bone Cement

Symphony™ VR Radiopaque Bone Cement is indicated for the Intended Use: fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

The following table compares the chemical composition of Symphony™ VR Radiopaque Bone Cement compared to the predicate devices.

| Chemical Composition | Symphony™ VR | KyphX® HV-R | Stryker Spineplex™ |
|--------------------------------------------------------------------------|----------------------------------------------|----------------------------------------------|----------------------------------------------|
| Powder | 20 g (half-dose) Bottle<br>of Sterile Powder | 20 g (half-dose) Packet<br>of Sterile Powder | 20 g (half-dose) Packet<br>of Sterile Powder |
| Polymethyl<br>Methacrylate / Methyl<br>Methacrylate-styrene<br>copolymer | 71.3% w/w | 68.0% w/w | 69.1% w/w |
| Barium sulfate | 28.0% w/w | 30.0% w/w | 30.0% w/w |
| Benzoyl peroxide | 0.7% w/w | 2.0% w/w | 0.9% w/w |
| Liquid | 8.2g (half-dose) Vial of<br>Sterile Liquid | 9.0g (half-dose) Vial of<br>Sterile Liquid | 9.4 (half-dose) Vial of<br>Sterile Liquid |
| Methyl Methacrylate | 99.0% v/v | 99.1% v/v | 97.4% v/v |
| N: N Dimethyl-p-<br>toluidine | 1.0% v/v | 0.9% v/v | 2.6% v/v |
| Hydroquinone | 100 ppm | 75 ppm | 75 ± 15 ppm |

## Summary:

Based on the device performance information provided in this premarket notification, SymphonyTM VR Radiopaque Bone Cement has been shown to be substantially equivalent to the currently marketed predicate devices. This device has the same intended use, functional characteristics, material properties, biocompatibility and clinical application as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white emblem or seal. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the outer edge. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked on top of each other.

Public Health Service

JAN 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John P. Carr Chief Operating Officer Advanced Biomaterial Systems 100 Passaic Avenue Chatham, New Jersey 07928

Re: K042168

Trade/Device Name: Symphony™VR Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate Bone Cement Regulatory Class: II Product Code: NDN Dated: December 17, 2004 Received: December 20, 2004

Dear Mr. Carr:

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 - Mr. John P. Carr

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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A Milhern

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Symphony™ VR Radiopaque Bone Cement Device Name:

Indications For Use:

Symphony™ VR Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/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)

Mark N. Melkerson

Division of General, Restorative, and Neurological Devices

510(k) Number