WAVEON WRX BONE FIXATION SYSTEM

K090304 · Sonoma Orthopedic Products, Inc. · HRS · Aug 28, 2009 · Orthopedic

Device Facts

• Record ID: K090304
• Device Name: WAVEON WRX BONE FIXATION SYSTEM
• Applicant: Sonoma Orthopedic Products, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Waveon™ WRx (WristRocket™ Distal Radius System) is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable: Joint destruction and/or subluxation visible on x-ray; Osteotomy and repair of distal radius malunion with or without bone graft; Non-displaced fractures. Transverse fractures of the distal radius with or without comminution (e.g. AO classifications A2 and A3); Transverse fractures of the distal radius with an extension into the joint with or without comminution (e.g. AO classification C2 and C1 respectively); Failed fracture fixation with or without bone graft for the types of fractures above; The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, C1 and C2) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

Device Story

WavEon™ WRx is a flexible intramedullary fixation device for distal radius fractures. It serves as a mechanical implant to stabilize bone fragments. Used by surgeons in clinical settings to treat unstable fractures where closed reduction fails. The device provides internal structural support to facilitate bone healing. It is a re-branding of the predicate Ensplint Rx with extended indications to include C2 distal radius fractures.

Clinical Evidence

No clinical trials were performed. Evidence consists of bench testing per ASTM 1264 and cadaver studies demonstrating the ability to safely insert, reduce, and fixate C2 fractures.

Technological Characteristics

Flexible intramedullary implant manufactured from stainless steel. Meets ASTM 1264 standards. Mechanical fixation device.

Indications for Use

Indicated for patients with unstable distal radius fractures requiring fixation where closed reduction is unsuitable, including joint destruction/subluxation, malunion osteotomy, non-displaced fractures, transverse fractures (AO A2, A3, C1, C2), and failed prior fixation.

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

• Ensplint Rx (K071809)

Submission Summary (Full Text)

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Ko90304 '/2

Sonoma Orthopedic Products, Inc. 650 Larkfield Center, Suite C Santa Rosa, CA 95403
Ph: 707-526-1335 Fax: [phone]

# 510(k) Summary

AUG 2 8 2009

| Submitter's name | Sonoma Orthopedic Products, Inc. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 650 Larkfield Center, Suite C<br>Santa Rosa, CA 95403 |
| Phone Number | 707-526-1335 ext. 255 |
| Fax Number | 707-540-6001 |
| Name of contact person | Carlos Gonzalez |
| Date summary was prepared | January 14, 2008 |
| Proprietary name/Trade name | WavEon™ WRx |
| Common Name | Intramedullary Distal Radius Fixation<br>Device |
| Classification Name | Plate, Fixation, Bone 21 CFR 888.3030, HRS |
| Predicate Device | Sonoma Orthopedic Products Inc.<br>Ensplint Rx, K071809 |
| Description of device | The WavEon™ WRx configuration consists<br>of a flexible implant manufactured from stainless<br>steel. |
| Intended use of device | The Waveon™ WRx (WristRocket™ Distal Radius System) is intended to be<br>used for the fixation of unstable distal radius fractures in which closed reduction<br>is not suitable: <ul><li>Joint destruction and/or subluxation visible on x-ray;</li><li>Osteotomy and repair of distal radius malunion with or without bone graft;</li><li>Non-displaced fractures.</li><li>Transverse fractures of the distal radius with or without comminution (e.g. AO classifications A2 and A3);</li><li>Transverse fractures of the distal radius with an extension into the joint with or without comminution (e.g. AO classification C2 and C1 respectively);</li><li>Failed fracture fixation with or without bone graft for the types of fractures above;</li><li>The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, C1 and C2) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.</li></ul> |
| Comparison to Predicate Device | The WavEon™ WRx is the new trade name,<br>for the Ensplint predicate device. This submission<br>extends the indications for use to C2 Distal Radius<br>Fractures (AO classification). Only minor<br>differences are incorporated in this model that do |

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K090304

Sonoma Orthopedic Products, Inc. 650 Larkfield Center, Suite C Santa Rosa, CA 95403 Ph: 707-526-1335 Fax: [phone]

not affect safety or effectiveness. Extended indications is requested to include C2 Distal Radius fractures.

### Performance Data (Non clinical)

Equivalent to the predicate, the WavEon™WVRx device meets the requirements of ASTM 1264. Further, cadaver studies demonstrate that the implant can be safely inserted, reduce and fixate C2 fractures. Therefore, the WavEon™WRx is substantially equivalent to the predicate and Safe and Effective for the extended application.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

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

Sonoma Orthopedic Products, Inc. % Mr. Carlos Gonzalez 650 Larkfield Center, Suite C Santa Rosa, CA 95403

Re: K090304

. Trade/Device Name: WavEon WRx Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

AUG 2 8 2009

Regulatory Class: II Product Code: HRS, HSB Dated: July 15, 2009 Received: July 21, 2009

Dear Mr. Gonzalez:

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Carlos Gonzalez

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehrig

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

Enclosure

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#### INDICATIONS FOR USE

#### 510(k) Number (if known): K090304

Device Name: WavEon™ WRx

Indications for Use:

The Waveon™ WRx (WristRocket™ Distal Radius System) is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:

- Joint destruction and/or subluxation visible on x-ray; .
- . Osteotomy and repair of distal radius malunion with or without bone graft;
- Non-displaced fractures.
- Transverse fractures of the distal radius with or without comminution (e.g. AO . classifications A2 and A3);
- . Transverse fractures of the distal radius with an extension into the joint with or without comminution (e.g. AO classification C2 and C1 respectively);
- Failed fracture fixation with or without bone graft for the types of fractures above; .
- The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, t C1 and C2) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Souther for MXM
(Division Sign off)

(DKision Sign-6 Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K090304