MONDEAL DISTAL RADIUS SYSTEM

K071798 · Mondeal Medical Systems GmbH · HRS · Sep 17, 2007 · Orthopedic

Device Facts

• Record ID: K071798
• Device Name: MONDEAL DISTAL RADIUS SYSTEM
• Applicant: Mondeal Medical Systems GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Sep 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

Device Story

The Mondeal® Distal Radius System is an orthopedic implant set for internal fixation of distal radius fractures and osteotomies. The system comprises titanium plates (CP Titanium Grade 2) and screws (Ti-6Al-4V ELI) of varying lengths (8-38 mm) and diameters (2.7 or 3.0 mm). Plates feature dorsal and volar 'T' configurations. The device is used by surgeons in a clinical/OR setting to stabilize bone segments. Implants are supplied non-sterile in tempered plastic or stainless steel trays, requiring steam sterilization by the user prior to implantation. The system provides mechanical stability to the fracture site, facilitating bone healing. Manual reusable surgical instruments are provided to assist in the implantation procedure.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing comparing mechanical properties (hardness, yield/tensile strength, elongation, reduction in area) and material characteristics against the predicate device.

Technological Characteristics

System consists of CP Titanium Grade 2 plates and Ti-6Al-4V ELI screws. Components are non-sterile, intended for steam autoclave sterilization. Form factor includes dorsal and volar 'T' shaped plates and 2.7/3.0 mm diameter screws. Mechanical properties are comparable to predicate. No software or electronic components.

Indications for Use

Indicated for fixation of fractures and osteotomies of the distal radius in patients requiring internal fixation via volar or dorsal application.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Mondeal® Radius HO System (K050655)

Submission Summary (Full Text)

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# Mondeal® Distal Radius System 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is Kon1798 . This Summary was prepared on August 27, 2007

#### GENERAL INFORMATION

#### Manufacturer and Applicant Information:

Mondeal Medical Systems GmbH Moltkestr. 39 Tuttlingen, GERMANY 78532 Contact: Jay Evans Telephone: [phone] Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: [phone]

#### Trade Name:

Device Name: Mondeal® Distal Radius System Common Name: Screw, Fixation, Bone and Plate, Fixation, Bone Classification Name: Plate, Fixation, Bone, Class II and Regulation: 21 CFR 888.3030, 87HRS

#### Substantial Equivalence:

Mondeal Medical Systems GmbH, claims substantial equivalence to the Mondeal® Radius HO System, K050655.

Indications for Use:

The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

#### Description of the Device

The Mondeal® Distal Radius System consists of titanium volar and dorsal plates with shapes and sizes designed for internal fixation of distal radius fractures and osteotomies, and screws of varying lengths from 8 to 38 mm and 2.7 or 3.0 mm in diameter, supplied non-sterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include dorsal and volar "T" shaped right and configurations. Manual reusable surgical instruments may be supplied to facilitate implantation.

SEP 17 2007

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## ATTACHMENT III - 510(k) SUMMARY, REVISED

| Characteristic | Mondeal® Distal Radius System | Mondeal® Radius HO System |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Names | Mondeal® Distal Radius System | Mondeal® Radius HO System |
| 510(k) number | TBD | K050655 |
| Indications for use | The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect. | The Mondeal® RADIUS HO System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect. |
| Design and Device Characteristics | | |
| Technology | Titanium plates and screws | Titanium plates and screws |
| Application | Internal Fixation of small bones of hand and foot | Internal Fixation of small bones of hand and foot |
| Design / Components | CP Titanium Grade 2 plates and Ti-6Al-4V ELI screws | Ti-6Al-4V ELI Anodized Type II plates and screws |
| Performance Specifications | | |
| Corrosion resistance | Identical | Identical |
| Mechanical properties | Similar hardness, yield and tensile strength, elongation, reduction in area, chemical content | Similar hardness, yield and tensile strength, elongation, reduction in area, chemical content |
| Sterilisation Method | Steam Autoclave | Steam Autoclave |
| Packaging | Tempered plastic and or stainless steel trays suitable for steam sterilization including plate, screw, and hand tools (Class I) assortment, plates and screws also packaged individually, all non-sterils, intended for sterilization by purchaser | Tempered plastic and or stainless steel trays suitable for steam sterilization including plate, screw, and hand tools (Class I) assortment, plates and screws also packaged individually, all non-sterils, intended for sterilization by purchaser |

### Device Comparison

### Conclusions

Mondeal Medical Systems GmbH considers the Mondeal® DISTAL RADIUS System to be substantially equivalent to the aforementioned predicate devices with regard to intended use, materials, biocompatibility, and overall performance characteristics in accordance with the above comparison summary.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mondeal Medical Systems, GmbH % Mr. Jay Evans Mondeal North America, Inc. 13566 Freeport Road San Diego, California 92133

SEP 1 7 2007

Re: K071798

> Trade/Device Name: Mondeal® Distal Radius System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: August 28, 2007 Received: September 4, 2007

Dear Mr. Evans:

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, RDA over 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

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Page 2 - Mr. Jay Evans

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/cdrh/industry/support/index.html.

Sincerely yours,

Barbara buelin
for

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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# Indications for Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Mondeal® Distal Radius System

Indications For Use:

The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

Prescription Use X (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)

Dalvara Buchen
(Division Sign-Off)

Division of Ge eral, Restorative. and Neurological Devices

**510(k) Number** K07196

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Mondeal® Distal Radius System Mondeal Medical Systems, GmbH. Traditional 510(k) Application Page 37 of 63