BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60

K123225 · Aap Biomaterials GmbH & Co. KG · LOD · Mar 15, 2013 · Orthopedic

Device Facts

• Record ID: K123225
• Device Name: BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
• Applicant: Aap Biomaterials GmbH & Co. KG
• Product Code: LOD · Orthopedic
• Decision Date: Mar 15, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BonOs R bone cement 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.

Device Story

BonOs R is a fast-setting, radiopaque PMMA bone cement used in orthopedic surgery to fix prosthetic implants to bone. It consists of two sterile components: a powder (polymethyl methacrylate/acrylate, benzoyl peroxide initiator, zirconium dioxide radiopacifier) and a liquid (methyl methacrylate monomer, N,N-dimethyl-p-toluidine activator, stabilizer). Upon mixing, the activator initiates polymerization, creating a viscous paste that is applied to the surgical site. The material cures at room temperature via an exothermic reaction, providing mechanical fixation of the implant and transferring stresses to the bone. It is intended for use by surgeons in clinical settings.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through comparative physical, chemical, and mechanical testing against the predicate device.

Technological Characteristics

Two-component self-polymerizing PMMA system. Powder: poly(methyl acrylate, methyl methacrylate), di-benzoyl peroxide, zirconium dioxide. Liquid: methyl methacrylate (stabilized with hydroquinone), N,N-dimethyl-p-toluidine. Polymerization initiated by mixing components at room temperature. Radiopaque. Class II device per 21 CFR 888.3027.

Indications for Use

Indicated for fixation of polymer or metallic prosthetic implants to living bone during arthroplastic procedures of the hip, knee, and other joints.

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

• Palacos R (K030902)

Submission Summary (Full Text)

{0}------------------------------------------------

| aap Biomaterials GmbH<br>Lagerstraße 11 – 15 | BonOs R | 164-0034-01 |
|----------------------------------------------|-------------------------------------|----------------|
| 64807 Dieburg | | Date of issue: |
| Germany | 5. 510(k) Summary | 11.10.2012 |
| | 510(k) Premarket Notification PO-34 | page 1 of 3 |

# 5. 510(k) summary

# MAR 1 5 2013

:

K12322

ധ

. :

| Preparation date: | 11.10.2012 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | aap Biomaterials GmbH<br>Lagerstraße 11-15<br>64807 Dieburg<br>Germany<br>Phone: +49 6071 / 929-0<br>Fax: +49 6071 / 929-100 |
| Contact person: | Volker Stirnal |
| Trade name: | BonOs R |
| Common name: | PMMA Bone Cement |
| Classification: | Polymethylmethacrylate (PMMA) Bone Cement<br>21 CFR 888.3027, Class II |
| Product Code: | LOD |
| Panel: | Orthopedics |

# Predicate device to which substantial equivalence is claimed:

.

:

.

:

| Manufacturer | Device Name | 510(k) # |
|--------------|-------------|-----------|
| Heraeus | Palacos R | (K030902) |

{1}------------------------------------------------

| aap Biomaterials GmbH<br>Lagerstraße 11 – 15<br>64807 Dieburg<br>Germany | BonOs R<br>5. 510(k) Summary<br>510(k) Premarket Notification PO-34 | 164-0034-01<br>Date of issue:<br>11.10.2012<br>page 2 of 3 |
|--------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------|
|--------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------|

#### Device description:

BonOs R is a fast-setting acrylic resin for use in bone surgery. The bone cement is made of two separate sterile components. When both cement components are mixed together, they become a self hardening, radlopaque bone cement which fixes the implant and transfers stressesevenly to the bone.

### Scientific concepts, significant physical and performance characteristics:

Bone cements in general are self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together.

The major powder component is polymethyl methacrylate / acrylate. Furthermore a radio-opacifier and benzoyl peroxide as an initiator is Included.

The liquid mainly consists of methyl methacrylate. It is furthermore comprised of an activator and a stabilizer to prevent premature polymerization.

When the powder and liquid components are mixed together, the activator, DmpT, contained in the liquid activates the initiator in the powder component. This reaction starts the polymerization of the MMA, which is bonded with the polymer powder during ongoing polymerization. A description of polymerization technology is depictured in section 10- Executive summary, annex 10 - A.

As a result, a viscous paste is obtained which can be introduced into bone using a suitable application system. Heat is generated during setting as a result of the progressive polymerization and exothermlc reaction respectively. After curing, the bone cement is able to fix the implant. The setting or curing time is greatly influenced by the temperature of the components and environment, which Is common for all acrylic bone cements.

#### Statement of the intended use:

The BonOs R bone cement 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.

### Summary of technological characteristics of the new device in comparison to the predicate devices:

BonOs R bone cement comprises the same materials, mechanical safety and performance as the legally marketed device Palacos R.

5 - 2

{2}------------------------------------------------

| aap Biomaterials GmbH<br>Lagerstraße 11 – 15<br>64807 Dieburg<br>Germany | BonOs R<br>5. 510(k) Summary<br>510(k) Premarket Notification PO-34 | 164-0034-01<br>Date of issue:<br>11.10.2012<br>page 3 of 3 |
|--------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------|
|--------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------|

| | Trade Name | | BonOs R | Palacos R | |
|-------------------------------|------------|---------------|---------------------------------------------------------|----------------------------------------------------------|--|
| Common name | | | PMMA Bone<br>Cement | PMMA Bone<br>Cement | |
| Responsible<br>manufacturer | | | aap Biomaterials | Heraeus Kulzer | |
| 510(k) Number | | | | K030902 | |
| Device Classification<br>Name | | | Cement, Bone | Cement, Bone | |
| Product Code | | | LOD | LOD | |
| Classification | | | Class II | Class II | |
| Regulation no. | | | 21 CFR 888.3027 | 21 CFR 888.3027 | |
| Materia | | Polymer | Poly(methyl<br>acrylate, methyl<br>methacrylate) | Poly(methyl<br>acrylate, methyl<br>methacrylate)* | |
| | Powder | Initiator | Di-benzoyl<br>peroxide | Di-benzoyl<br>peroxide | |
| | | Radiopacifier | Zirconium dloxIde | Zirconium dioxide | |
| | iquid | Monomer | Methylmethacrylate<br>(stabilized with<br>hydroquinone) | Methyimethacrylate<br>(stabilized with<br>hydroquinone)* | |
| | | Activator | N,N-dimethyl-p-<br>toluidine | N,N-dimethyl-p-<br>toluldine | |

contains Chlorophyll Copper Complex *

BonOs R is substantially equivalent to Palacos R (K030902) in regard to intended use, materials and operational principles as a bone cement. Intellate ably materified by physical, chemical and mechanical comparative tests to Palacos R.

In summary, BonOs R bone cement is as safe and effective for the declared indications as the predicate device, Palacos R.

5 - 3

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HEALTH & HUMAN SERVICES - USA" are arranged in a semi-circle around the top of the symbol, and the word "DEPARTMENT" is at the bottom.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 15, 2013

aap Biomaterials GmbH % Mr. Volker Stirnal Director Quality Assurance and Regulatory Affairs Lagerstrasse 11-15 64807 Dieburg Germany

Re: K123225

Trade Name: BonOs R Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD Dated: January 28, 2013 Received: February 1, 2013

Dear Mr. Stirnal:

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 Part 801); medical device reporting (reporting of medical

{4}------------------------------------------------

### Page 2 - Mr. Volker Stirnal

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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin-I.D.Keith

Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

| aap Biomaterials GmbH<br>Lagerstraße 11 – 15<br>64807 Dieburg<br>Germany | BonOs R<br>4. Indications for Use Statement | 164-0033-01 |
|--------------------------------------------------------------------------|---------------------------------------------|----------------|
| | 510(k) Premarket Notification PO-34 | Date of issue: |

## 4. Indications for Use

510(k) Number: K123225

Device Name: BonOs R

Indications for Use:

BonOs R 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.

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 CDRH, Office of Device Evaluation (ODE)

Laurence D. (Soyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123225