OSTEOPAL plus

K153737 · Heraeus Medical GmbH · LOD · Apr 22, 2016 · Orthopedic

Device Facts

• Record ID: K153737
• Device Name: OSTEOPAL plus
• Applicant: Heraeus Medical GmbH
• Product Code: LOD · Orthopedic
• Decision Date: Apr 22, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OSTEOPAL® plus bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

Device Story

OSTEOPAL® plus is a radiopaque, low-viscosity PMMA bone cement; contains zirconium dioxide (X-ray contrast) and chlorophyll VIII (coloring agent). Prepared by mixing polymer powder and liquid monomer components immediately before use. Applied via application system into vertebral body; cures in situ to stabilize fractures. Used in clinical settings (e.g., OR) by physicians performing vertebroplasty or balloon kyphoplasty. Extended application phase allows longer working time for vertebral augmentation procedures. Provides structural support to fractured vertebrae; benefits patients by stabilizing lesions and reducing pain.

Clinical Evidence

No clinical data was provided. Substantial equivalence is supported by non-clinical bench testing, including characterization of maximum temperature, setting time, compressive strength, bending modulus, and bending strength per ISO 5833, as well as biocompatibility testing (cytotoxicity, irritation, sensitization, acute systemic toxicity) per ISO 10993.

Technological Characteristics

PMMA-based bone cement; powder/liquid components. Contains zirconium dioxide (contrast) and chlorophyll VIII. Characterized per ISO 5833 (compressive strength, bending modulus/strength). Sterilization: EtO (ISO 11135). Low-viscosity formulation with extended setting time compared to predicate.

Indications for Use

Indicated for patients with pathological vertebral body fractures caused by osteoporosis, cancer, or benign lesions requiring vertebroplasty or balloon 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

• OSTEOPAL® V (K050085)

Reference Devices

• PALACOS® R (K030902)

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

April 22, 2016

Heraeus Medical GmbH % Mr. Gordon MacFarlane Senior Manager Regulatory Affairs ICON plc 62 Forest Street Marlborough, Massachusetts 01752

Re: K153737

Trade/Device Name: OSTEOPAL® plus Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD, NDN Dated: March 15, 2016 Received: March 24, 2016

Dear Mr. MacFarlane:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

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/Resourcesfor You/Industry/default.htm. 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 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

| Indications for Use |
|---------------------|
|---------------------|

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

| 510(k) Number (if known) | K153737 |
|--------------------------|---------|
|--------------------------|---------|

# əmin əsinə q

OSTEDPAL® plus

OSTEOPAL® plus

| Indications for Use (Describe) | OSTEOPAL® plus bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Type of Use (Select one or both, as applicable) | <div> <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# Heraeus Heraeus Medical GmbH 61273 Wehrheim, Germany

# OSTEOPAL® plus

#### Radiopaque bone cement for augmentation

of vertebral bodies

Special 510(k)

510(k) Summary

| Date of summary | March 15th, 2016 |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant's name and address | Heraeus Medical GmbH<br>Philipp-Reis-Straße 8/13<br>61273 Wehrheim<br>Germany |
| Device trade name | OSTEOPAL® plus |
| Common name | PMMA Bone Cement |
| Classification | PMMA Bone Cement : Class II special control per 21 CFR<br>888.3027 |
| Classification name | Polymethylmethacrylate (PMMA) bone cement |
| Product code | LOD, NDN |
| Identification of the marketed device to which equivalence is claimed | OSTEOPAL® V, K050085 |
| Description of the device | OSTEOPAL® plus is a radiopaque, low-viscosity bone<br>cement, based on polymethyl methacrylate with an<br>extended application phase, used to fill and stabilize<br>vertebral bodies. OSTEOPAL® plus contains zirconium<br>dioxide as an X-ray contrast agent. OSTEOPAL® plus<br>contains the coloring agent chlorophyll VIII (E141) to<br>improve visibility in the surgical field. The bone cement<br>is prepared immediately prior to use by mixing the<br>polymer powder component and the liquid monomer<br>component. A low viscosity paste is applied with the<br>use of application system, placed in the vertebral<br>body, where it cures. OSTEOPAL® plus conforms to |

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#### OSTEOPAL® plus

Image /page/4/Picture/1 description: The image shows the logo for Heraeus Medical GmbH. The logo consists of the word "Heraeus" in a bold, sans-serif font, with the words "Heraeus Medical GmbH" printed below it. The address "61273 Wehrheim, Germany" is printed below the company name. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.

# Radiopaque bone cement for augmentation of vertebral bodies

| Special 510(k) | 510(k) Summary |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | OSTEOPAL® plus bone cement is indicated for the<br>treatment of pathological fractures of the vertebral body<br>due to osteoporosis, cancer, or benign lesions using a<br>vertebroplasty or balloon kyphoplasty procedure. |
| Comparison of technological<br>characteristics | Bone cement is derived by mixing a powder component<br>and a monomer liquid. The only difference between the<br>subject and predicate device is a change to the<br>monomer liquid composition and therefore an extended<br>setting time. |
| Discussion of nonclinical tests | The maximum temperature, setting time, compressive<br>strength, bending modulus and bending strength of<br>OSTEOPAL® plus was characterized per ISO 5833.<br>Both the subject and predicate device disclose a higher<br>curing time, with OSTEOPAL® plus displaying an even<br>increased setting time. These prolonged working phases<br>are needed because for augmentation of vertebral bodies<br>longer setting times than described in ISO 5833 are<br>necessary. Therefore, the later setting time is<br>advantageous. In addition, impact and bending strength<br>were measured according to Dynstat test method. EtO<br>sterilization was validated per ISO 11135.<br>Biocompatibility testing, including cytotoxicity, irritation,<br>sensitization, acute systemic toxicity was performed per<br>ISO 10993.<br>AS PALACOS® R, K030902 (the predicate device for<br>polymerized OSTEOPAL® V) is made of the same<br>material constituents as OSTEOPAL® plus and the<br>performed tests regarding genotoxicity are very<br>sensitive it is reasonable that the results are |
| Special 510(k) | 510(k) Summary |
| | transferable. Thus it can be concluded that<br>OSTEOPAL® plus is not genotoxic. |
| | |
| Clinical performance data | No clinical data was provided. |
| Conclusions from nonclinical<br>and clinical data | OSTEOPAL® plus is substantial equivalent to<br>OSTEOPAL® V. |
| Submitted by | Dr. Astrid Marx |
| | Phone: + 49 (0) 6181.35-2963 |
| | Fax: + 49 (0) 6181.35-2916 |
| | [e-mail] |
| US contact information | ICON plc, |
| | Gordon MacFarlane, |
| | 62 Forest Street Suite 300, Marlborough, MA 01752 |
| | Tel: [phone] |
| | [e-mail] |

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### OSTEOPAL® plus

Image /page/5/Picture/1 description: The image shows the logo and address of Heraeus Medical GmbH. The logo is a stylized wordmark with the company name "Heraeus" in a bold, sans-serif font. Below the logo is the company's name and address, which is "Heraeus Medical GmbH, 61273 Wehrheim, Germany."

# Radiopaque bone cement for augmentation of vertebral bodies