DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW

K132704 · Biomet · LXT · Oct 9, 2013 · Orthopedic

Device Facts

• Record ID: K132704
• Device Name: DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
• Applicant: Biomet
• Product Code: LXT · Orthopedic
• Decision Date: Oct 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.

Device Story

Distal Radius Volar Rim Plating System consists of metallic plates and screws used for bone fixation in distal radius fractures, malunions, and osteotomies. Device components include plates in narrow to standard head widths, utilizing non-locking, locking, and variable angle screws. Used by orthopedic surgeons in clinical/surgical settings to stabilize bone segments during reconstructive surgery. Provides mechanical support to facilitate bone healing. No software or electronic components.

Clinical Evidence

Bench testing only. Testing included axial load construct testing, galvanic corrosion potential evaluation, and tab bending and function testing.

Technological Characteristics

Materials: Titanium alloy and CoCr. Components: Plates (narrow to standard head widths) and screws (non-locking, locking, variable angle). Mechanical fixation device.

Indications for Use

Indicated for fixation of fractures, malunions, and osteotomies of the distal radius in patients requiring surgical bone stabilization.

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

• Distal Volar Radius Plating System (K112345)

Submission Summary (Full Text)

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## K132704 page 1 of 1

## Section 5 - 510(k) Summary

| Submitted by: | Biomet Trauma<br>56 East Bell Drive<br>PO Box 587<br>Warsaw, IN 46581<br>Phone: [phone]<br>Fax: [phone] | OCT 0 9 2013 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Suzana Otaño, Global Project Manager, Regulatory Affairs | |
| Date Prepared: | August 27, 2013 | |
| Proprietary Name: | Distal Radius Volar Rim Plating System | |
| Common Name: | Plate, Fixation, Bone | |
| Classification Name: | Single/multiple component metallic bone fixation appliances and<br>accessories (21 CFR § 888.3030) | |
| Predicate Devices: | The Distal Radius Volar Rim Plating System is substantially<br>equivalent to currently marketed Distal Volar Radius Plating System<br>(K112345). | |
| Device Description: | The Distal Radius Volar Rim Plating System consists of a series of<br>plates utilizing non-locking, locking and variable angle screws<br>manufactured from Titanium alloy and CoCr used in bone fixation<br>and the management of fractures and reconstructive surgeries in<br>narrow to standard head widths. | |
| Indications for Use: | The system is intended for fixation of fractures, malunions and<br>osteotomies involving the distal radius. | |
| Technological<br>Characteristics: | The technological characteristics of the Distal Radius Volar Rim<br>Plating System are similar to the predicate devices including design,<br>dimensions and material. | |
| Summary of<br>Substantial<br>Equivalence: | The Distal Radius Volar Rim Plating System is substantially<br>equivalent to currently marketed devices as demonstrated with pre-<br>clinical data including axial load construct testing, evaluation of<br>galvanic corrosion potential, tab bending and function. No new<br>issues of safety or efficacy have been raised. | |

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird, which is the department's official symbol.

Public Heatth Service

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

October 9, 2013

Biomet, Inc. Ms. Suzana Otaño Global Project Manager, Regulatory Affairs P.O. Box 587 Warsaw, Indiana 46581

Re: K132704

Trade/Device Name: Distal Radius Volar Rim Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: LXT Date: August 27, 2013 Received: August 29, 2013

Dear Ms. Otaño:

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 advises, good mease 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 or any i 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

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## Page 2 – Ms. Suzana Otaño

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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.

ErinIDKeith

for

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

Enclosurc

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Section 4 - Indications for Use Statement

| 510(k) Number: | K132704 |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Device Name: | Distal Radius Volar Rim Plating System |
| Indications For Use: | The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius. |

| scription Use | X | AND/OR | Over-the-Counter |
|---------------|---|--------|------------------|
|---------------|---|--------|------------------|

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

Over-the-Counter AND/OR (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)

## Elizabeth L. Frank -S

Division of Orthopedic Devices

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Distal Radius Volar Rim System · Traditional 510(k) Biomet Trauma

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