VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES

K100271 · Howmedica Osteonics Corp. · HRS · May 14, 2010 · Orthopedic

Device Facts

• Record ID: K100271
• Device Name: VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
• Applicant: Howmedica Osteonics Corp.
• Product Code: HRS · Orthopedic
• Decision Date: May 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker® XXL Volar Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.

Device Story

System consists of XXL-sized pre-contoured metallic bone plates and associated screws/pegs for internal fixation of distal radius fractures and reconstructions. Plates feature 5, 8, 11, or 15 hole options with 2mm distal and 3mm shaft profile heights; designed for palmar, dorsal, or orthogonal application. Screws are self-tapping with cross-pin or torx heads. Device used by orthopedic surgeons in clinical/surgical settings to stabilize bone segments; facilitates bone healing via rigid fixation. Output is physical stabilization of bone; clinical decision-making relies on surgeon assessment of fracture type and anatomical fit. Benefits include restoration of bone alignment and structural integrity.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation plates and screws. Features pre-contoured geometry for radial bow, 2mm distal profile, 3mm shaft profile, and gliding holes for alignment. Includes locking screws, bone screws, locking pegs, and partially threaded screws with self-tapping capability. Torx or cross-pin head configurations.

Indications for Use

Indicated for internal fixation of fractures and reconstruction of small bones, primarily the distal radius, in patients requiring treatment for compression, intra-articular, extra-articular, or displaced fractures, as well as osteotomies, non-unions, and mal-unions.

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

• Stryker Leibinger Universal Distal Radius System (K040022)
• Synthes Diaphyseal-Metaphyseal Volar Distal Radius Plate (K070946)
• Zimmer Periarticular Locking Plate System (K040593)

Reference Devices

• Distal Radius Torx Screws (K080667)

Submission Summary (Full Text)

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K100271 (1/2)

# MAY 1 4 2010

# 510(k) Summary of Safety and Effectiveness

| Proprietary Name: | VariAx Distal Radius Line Extension of XXL Plates |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone plates and screws |
| Classification Name and Reference: | Single/multiple component metallic bone fixation appliances and accessories 21 CFR §888.3030 |
| Regulatory Class: | Class II |
| Product Codes: | HRS: Plate, Fixation, Bone |
| For Information contact: | Melissa Matarese, Regulatory Affairs Associate<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone] Fax: [phone] |
| Date Prepared: | October 20, 2009 |

# Description:

Homedica Osteonics is extending the Variax Distal Radius Plates of the Variax Distal Radius Plating System to include XXL sized plates as well as to modify the indications for use for the XXL Volar Distal Radius Plates to include Osteotomies, non-unions and mal-unions.

Each plate will accept a locking screw, bone screws, locking pegs, and partially threaded screws. The XXL plates are precontoured performed for palmer, fixation. Screws are selftapping and have either cross-pin or torx heads.

Plates are offerered in 5,8,11,and 15 hole options with a 2mm distal profile height and 3mm profile shaft height. All plates are straight and pre-contoured to fit the radial bow beyond the shaft. Gliding holes all for allignment of the plate and allow for additional bone reduction if required.

# Intended Use:

The Stryker® XXL Volar Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and

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extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.

# Indications:

The indications for use of The Stryker® XXL Volar Distal Radius Plates include:

The Stryker® XXL Volar Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.

#### Substantial Equivalence:

The VariAx Distal Radius Line Extension of XXL Plates is substantially equivalent to other commercially available plate systems in regard to intended use, design materials and operational The following devices are examples of predicate systems: Stryker Leibinger principles. Universal Distal Radius System (K040022) which is marketed under the name of VariAx Distal Radius System, Synthes Diaphyseal-Metaphyseal Volar Distal Radius Plate (K070946), and Zimmer Periarticular Locking Plate System (K040593). Based upon the mechanical testing, the VariAx Distal Radius Line Extension of XXL Plates is substantially equivalent for its intended use to other plating systems currently on the market. Also, the Distal Radius Torx Screws are compatible with this system (K080667).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters.

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

MAY 1 4 2010

Howmedica Osteonics Corporation % Ms. Melissa Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, New-Jersey-07430

Re: K100271

Trade/Device Name: VariAX Distal Radius Line Extension of XXL Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 29, 2010 Received: April 30, 2010

Dear Ms. Matarese:

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. Iisting 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

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Page 2 - Ms. Melissa Matarese

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.

Mark M. Millers

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): | | 0027 |

Device Name: VariAx Distal Radius Line Extension of XXL Plates

Indications for Use:

The indications for use of the Distal Radius System:

The Stryker® XXL Volar Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.

Over-The-Counter Prescription . Use X Use - AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ooutu of mxa

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100271