VARIAX ELBOW SYSTEM PLATE LINE EXTENSION

K093433 · Howmedica Osteonics Corp. · HRS · Jan 28, 2010 · Orthopedic

Device Facts

• Record ID: K093433
• Device Name: VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
• Applicant: Howmedica Osteonics Corp.
• Product Code: HRS · Orthopedic
• Decision Date: Jan 28, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Variax Elbow System Plate Line Extension is intended for fracture fixation of long bones. Indications include distal humerus and proximal ulna.

Device Story

System consists of metallic bone plates and screws used for fracture fixation of long bones, specifically distal humerus and proximal ulna. Device is an extension of existing VariAx Elbow System; modifications include shortening of distal posterior medial humeral plates and internal process changes. Plates and screws are implanted by surgeons in clinical settings to stabilize bone fractures. Device provides mechanical support to facilitate bone healing.

Clinical Evidence

Bench testing only; no clinical data provided. Mechanical testing demonstrated substantial equivalence in strength and functional properties to the predicate device.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) and Commercially Pure Titanium. Form factor: Bone plates and screws for elbow fixation. Sterilization: Not specified (identical to predicate). Connectivity: None. Software: None.

Indications for Use

Indicated for fracture fixation of long bones, specifically distal humerus and proximal ulna.

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

• VariAx Elbow System (K073527)

Submission Summary (Full Text)

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### VARIAX ELBOW SYSTEM PLATE LINE EXTENSION

Special 510(k)

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093433

## 510(k) Summary of Safety and Effectiveness: Variax Elbow System Plate Line Extension

Nov 2, 2009

## JAN 2 8 2010

## Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430

For Information contact:

Melissa A. Matarese, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: [phone] Fax: [phone]

Date Summary Prepared:

Device Identification Proprietary Name:

Variax Elbow System Plate Line Extension

Common Name: Classification Name and Reference:

Device Product Code:

Bone plates and screws Single/multiple component metallic bone fixation appliances and accessories, 21 CFR §888.3030

HRS: Plate, Fixation, Bone

### Description:

The subject VariAx Elbow System is comprised of plates and screws, manufactured from Titanium alloy and Commercially Pure Titanium. The subject system was determined substantially quivalent in K073527. This Special 510(k) submission is intended to address the shortening of the Distal Posterior Medial Humeral Plates, left and right. Two process changes, which have been documented internally and affect the entire Distal Posterior Medial humeral Plate family, are also discussed.

#### Intended Use:

The Variax Elbow System Plate Line Extension does not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject plates are provided below.

#### Indications for Use:

The Variax Elbow System Plate Line Extension is intended for fracture fixation of long bones. Indications include distal humerus and proximal ulna.

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#### VARIAX ELBOW SYSTEM PLATE LINE EXTENSION

## Statement of Technological Comparison:

The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design. Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devise in regards to mechanical strength. In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical.

The subject and predicate devices are made from Titanium alloy (Ti-6Al-4V) and Commercially Pure Titanium. Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject Variax Elbow System Plate Line Extension to the predicate device VariAx Elbow System K073527.

ู้จัก

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right is a stylized representation of a bird or abstract human figure, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

JAN 2 8 2010

Re: K093433

Trade/Device Name: VariAx Elbow System Plate Line Extension Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and

accessories

Regulatory Class: II Product Code: HRS Dated: January 14, 2010 Received: January 19, 2010

Dear Ms. Matarese: ·

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 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.

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Page 2 - Ms. Melissa A. Matarese

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/CDRHQffices/ucm11.5809.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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Aoubara buekn

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): K ○93イタミ

Device Name: VariAx Elbow System Plate Line Extension

Indications For Use:

. .

The Variax Elbow System Plate Line Extension is intended for fracture fixation of long bones. Indications include distal humerus and proximal ulna.

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Smuta for Nixon
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093433

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