CONVENTUS DRS

K131552 · Conventus Orthopaedics · HRS · Feb 12, 2014 · Orthopedic

Device Facts

• Record ID: K131552
• Device Name: CONVENTUS DRS
• Applicant: Conventus Orthopaedics
• Product Code: HRS · Orthopedic
• Decision Date: Feb 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Conventus DRSTM is intended for the fixation of distal radius fractures.

Device Story

Conventus DRS is an intramedullary fracture fixation device for distal radius fractures. System components include an expandable scaffold, fragment screws, and a proximal plate. Device remains flexible during surgical placement to facilitate positioning, then transitions to a rigid state upon completion of the implant procedure. Used by orthopedic surgeons in a clinical/surgical setting. Implant materials consist of titanium alloy (Ti6Al4V) and Nitinol. Device provides mechanical stabilization of bone fragments to support healing.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and adherence to FDA guidance for MR safety and compatibility.

Technological Characteristics

Intramedullary fixation device. Materials: Titanium alloy (Ti6Al4V) and Nitinol. Components: Expandable scaffold, fragment screws, proximal plate. Mechanical principle: Flexible during insertion, rigid upon deployment. MR Conditional.

Indications for Use

Indicated for the fixation of distal radius fractures in patients requiring surgical 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

• Conventus DRSTM (K102689)

Submission Summary (Full Text)

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## 5. 510(k) Summary

·

FEB 1 2 2014

| Company: | Conventus Orthopaedics, Inc.<br>10200 73rd Avenue North, Suite 122<br>Maple Grove, MN 55369 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Conventus DRSTM |
| Common Name: | Fracture Fixation Device |
| Contact: | Kent R. Lind<br>Vice President, Quality and Regulatory<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | May 30, 2013 |
| Classification: | 21 CFR 888.3030, Single/multiple component metallic bone<br>fixation appliances and accessories<br>21 CFR 888.3020: Intramedullary fixation rod |
| Class: | II |
| Product Codes: | HRS and HSB |
| Indications for Use: | The Conventus DRSTM is intended for the fixation of distal<br>radius fractures. |
| Device Description: | The Conventus DRSTM is an intramedullary device intended<br>to treat distal radius fractures. The DRS is comprised of an<br>Expandable Scaffold, Fragment Screws, and a Proximal<br>Plate. The device remains flexible during placement, but is<br>made rigid at the completion of the surgical implant<br>procedure. The implant is made from titanium alloy<br>(Ti6Al4V) and Nitinol. |
| Substantial Equivalence: | The Conventus DRSTM is substantially equivalent to the<br>previously cleared Conventus DRSTM device (K102689).<br>Testing in accordance with FDA's Guidance Document<br>"Establishing Safety and Compatibility of Passive Implants<br>in the Magnetic Resonance (MR) Environment" was<br>performed and supports "MR Conditional" labeling for the<br>Conventus DRSTM device. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

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

February 12, 2014

Conventus Orthopaedics, Incorporated Mr. Kent Lind Vice President, Quality, Regulatory, Clinical 10200 73td Avenue North, Suite 122 Maple Grove, Minnesota 55369

Re: K131552

Trade/Device Name: Conventus DRS™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS. HSB Dated: January 13, 2014 Received: January 14, 2014

Dear Mr. Lind:

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

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## Page 2 - Mr. Kent Lind

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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/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 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,

## Lori A. Wiggins

for

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

Enclosure

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## Indications for Use 4.

11/2

.

:

2017-02-05

510(k) Number (if known): _K131552

Device Name: Conventus DRSTM

The Conventus DRS™ is intended for the fixation of distal radius fractures.

V Prescription Use __ (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (29 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)

Elizabeth に腕時nk -S

Division of Orthopedic Devices

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