CONTOURS VSP III VOLAR PLATING SYSTEM

K101936 · Orthofix, Inc. · HRS · Oct 20, 2010 · Orthopedic

Device Facts

• Record ID: K101936
• Device Name: CONTOURS VSP III VOLAR PLATING SYSTEM
• Applicant: Orthofix, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Oct 20, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Contours VPS III Volar Plating System is intended for the volar fixation of fractures and osteotomies involving the distal radius.

Device Story

Contours VPS III is an anatomically contoured, delta-shaped titanium alloy bone plate for volar fixation of distal radius fractures and osteotomies. Device features an angled head with two rows of screw holes for distal bone fragment stabilization and a shaft with K-wire and screw placement options. Includes a merged center hole/graft window for bone graft access or additional screw fixation. Used by orthopedic surgeons in clinical/OR settings to provide mechanical stabilization of bone segments. Output is physical fixation of the fracture site, facilitating bone healing. Device is supplied non-sterile and requires sterilization prior to implantation.

Clinical Evidence

Bench testing only. Mechanical properties of the modified plates were evaluated via uni-axial compression testing to compare strength and stiffness against the predicate device. Results demonstrated that the Contours VPS III exceeded all mechanical testing criteria.

Technological Characteristics

Material: Titanium alloy (Ti6Al4V ELI) per ASTM F136. Design: Delta-shaped, low-profile, anatomically contoured bone plate. Fixation: Bone screws. Dimensions: 3.4mm center thickness; various widths and lengths. Sterilization: Non-sterile, requires sterilization. Connectivity: None.

Indications for Use

Indicated for volar fixation of fractures and osteotomies of the distal radius 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

• Volar Distal Radial Plate (K042766)

Submission Summary (Full Text)

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

K10936
pg. 1/3

OCT 2 0 2010

## SUMMARY OF SAFETY AND EFFECTIVENESS

## Contours VPS III Volar Plating System

| Summary Date: | September 12, 2010 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | Mary E. Biggers, RAC / Orthofix Inc.<br>1720 Bray Central Drive<br>McKinney, TX 75609<br>972-824-4624 |
| Primary Contact: | Darla Chew / Directory, Regulatory Affairs/Orthofix Inc.<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Device Trade Name: | Contours VPS III Volar Plating System |
| Common Name: | bone plate |
| Regulation Name: | Single/multiple component metallic bone fixation appliances/<br>accessories. |
| Classification Name: | Plate, fixation, bone (21 CFR Parts 888.3030) |
| Product Code: | HRS |
| Indications for Use: | The Orthofix Contours VPS III is intended for volar fixation of fractures<br>and osteotomies involving the distal radius. |
| Predicate Device: | The Orthofix Inc. Contours VPS III is substantially equivalent in<br>design, function, and intended use to the Orthofix Volar Distal Radial<br>Plate. The Volar Distal Radial Plate, manufactured by Orthofix Inc. of<br>McKinney, TX, was originally cleared by FDA under K042766 on<br>November 16, 2004. |
| Device Description: | The Contours VPS is an anatomically contoured, delta-shaped plate<br>intended for volar applications to the distal radius. The Contours VPS<br>features an angled head with two rows of holes for placement of<br>screws distally on the radius to secure bone fragments and provide<br>stabilization. If a bone graft is required, access to the site is made<br>possible by the opening in the plate that spans from the plate head to<br>the distal portion of the shaft that may also be utilized for screw<br>placement. The shaft of the Plate is placed proximally on the distal<br>radius and offers a variety of K-wire and screw placement options for<br>secure fixation to the external surface of the bone. The device<br>provides the stabilization and fixation necessary in the treatment of<br>distal radius fractures and osteotomies. |

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

| Biomechanical | |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Testing | The mechanical properties of the modified Contours VPS III plates<br>were tested in uni-axial compression to determine if the modified<br>plates meet the same criteria for mechanical strength and stiffness as<br>the predicate device. The results of the testing demonstrated that the<br>Contours VPS exceeded all mechanical testing criteria. |
| Material: | The Contours VPS III plates and screws are made from titanium alloy,<br>Ti6AL-4V ELI conforming to ASTM F136. |
| Sterilization: | The Contours VPS III is supplied NON-STERILE and requires<br>sterilization prior to use. |
| Substantial | |
| Equivalence: | The Contours VPS III is substantially equivalent in design and function<br>to the Orthofix Inc. Volar Distal Radial Plate which received 510(k)<br>clearance under K042766 on 11-16-04 |

| Features | Orthofix Volar Distal Radial<br>Plate® | Contours VPS |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Intended for the volar fixation of<br>fractures and osteotomies<br>involving the distal radius. | Identical |
| Material | Implant grade Titanium<br>(Ti6A14V ELI) | Identical |
| Fixation Method | Bone Screws | Identical |
| Overall Design | One-piece, low-profile, concave<br>plate with multiple screw<br>attachment options in head and<br>shaft. | Identical |
| Plate Features:<br>- Graft/Screw Hole | Center hole<br>(separate) | Merged center hole with oval hole<br>for use as graft window or screw<br>hole |
| - Screw Holes | Linear arrangement of screw<br>holes | Non-linear arrangement of screw<br>holes; addition of two metaphyseal<br>screw holes |
| - Plate Thickness | 2.3mm-2.4mm | 3.4mm center plate thickness for<br>added strength |
| Plate Sizes | Left and right versions,<br>Three widths: 0.7 - 1.2 in. range<br>Five lengths: 2.0-4.0 in. range<br>(all 5 lengths available in each<br>width) | Left and right versions;<br>Three widths: 0.9 - 1.2 in. range<br>(narrow, standard, wide)<br>Three lengths: 2.0-4.3 in. range<br>(Narrow/wide plates offered in<br>short and long lengths; standard<br>width offered in short, long, &<br>extra long) |
| Plate Geometry | Delta-shaped | Delta-shaped |

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

## Conclusion:

Based upon the results of biomechanical testing, the modified Contours VPS III plates and expanded range of sizes is substantially equivalent to the Orthofix Volar Distal Radial Plate. The Contours VPS III has the mechanical properties needed to perform its indications for use and is considered to be substantially equivalent to the predicate device in design, intended use, material and function.

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

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three stripes representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding it.

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

Orthofix, Inc. % Ms. Mary E. Biggers, RAC 1720 Bray Central Drive McKinney, Texas 75609

OCT 2 0 2010

Re: K101936

Trade/Device Name: Contours VPS III Volar Plating System (bone plate) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and appliances Regulatory Class: II Product Code: HRS, HWC Dated: September 12, 2010 Received: September 24, 2010

Dear Ms. Biggers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have deterniined 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. Ilsting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Ms. Mary E. Biggers, RAC

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

[signature]

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

Enclosure

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

OCT 2 0 2010

## INDICATION FOR USE STATEMENT

Page / of l

510(k) Number (if known): _K101936

Device Name:

Contours VPS III Volar Plating System (bone plate)

Indications for Use:

The Contours VPS III Volar Plating System is intended for the volar fixation of fractures and osteotomies involving the distal radius.

Prescription Use: _ X (Per 21 CFR 801.109)

Or

Over-The-Counter (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sonuta fer mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101936