THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES

K102282 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · HRS · Dec 7, 2010 · Orthopedic

Device Facts

• Record ID: K102282
• Device Name: THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES
• Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
• Product Code: HRS · Orthopedic
• Decision Date: Dec 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VariAx™ Fibula Straight Plates are intended for use in internal fixation of the distal fibula.

Device Story

VariAx Fibula Straight Plates are metallic bone fixation implants; extension of VariAx Fibula plate line (K081284). Plates feature modified geometry, including shaft portion of existing plates and oblong screw holes. Used by surgeons for internal fixation of distal fibula fractures. Device provides mechanical stabilization of bone segments during healing. Performance verified via fatigue strength and stiffness testing compared to predicate systems.

Clinical Evidence

Bench testing only. Fatigue strength and stiffness analysis performed via 4-point bending tests. Results demonstrated equivalence to predicate Synthes One-Third Tubular DCL plates.

Technological Characteristics

Material: Titanium Grade 2 with type II anodization. Form factor: Bone plates with shaft and oblong screw holes. Energy source: N/A (mechanical implant). Connectivity: N/A. Sterilization: Not specified.

Indications for Use

Indicated for internal fixation of the distal fibula.

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 Fibula plate line (K081284)
• Synthes 3.5 mm LCP® Medial Distal Tibia Plates (K001945)
• Synthes One-Third Tubular Dynamic Compression Locking (DCL) (K011335)

Submission Summary (Full Text)

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K102282
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## 510(k) Summary of Safety and Effectiveness: VariAx" Locked Plating System Line Extension for Addition of Fibula Straight Plates

DEC - 7 2010

| Submission Information | |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp<br>325 Corporate Drive<br>Mahwah, NJ 07430 |
| For Information contact: | Stephanie M. Fitts, Director Regulatory<br>Affairs and Regulatory Compliance<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | November 29, 2010 |
| Device Identification | |
| Proprietary Name: | VariAxTM Locked Plating System Line<br>Extension for addition of Fibula Straight<br>Plates |
| Common Name: | Bone plates and screws |
| Classification Name and Reference: | Single/multiple component metallic bone<br>fixation appliances and accessories, 21 CFR<br>§888.3030 |
| Device Product Code: | 87 HRS: Plate, Fixation, Bone |

#### Description:

This 510(k) submission is intended to add bone plates with a different geometry to the VariAx " fibular plate line which was cleared in K081284. The new plates are termed "Fibula Straight Plates" and consist of the shaft portion of the cleared plate plus an oblong screw hole in some configurations. Additionally, other fixation plates (predicates) have been cleared with the approximate plate length of the subject device, including the Synthes 3.5 mm LCP® Medial Distal Tibia Plates (K001945) and Synthes One-Third Tubular Dynamic Compression Locking (DCL) (K011335).

#### Intended Use:

The VariAx " Fibula Locked Plating System Line Extension addition of Fibula Straight Plates does not alter the intended use of the predicate system as cleared in K081284. The indications for use for the subject plates are provided below.

#### Indications for Use:

The VariAx " Fibula Straight Plates are intended for use in internal fixation of the distal fibula.

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**Statement of Technological Comparison:**

The subject and predicate devices are made from Titanium Grade 2 with type II anodization. Fatigue strength verification and stiffness analysis were evaluated by way of a 4-point bending test. Median fatigue limits and stiffness of the subject VariAxTM Fibula Straight Plates were found equivalent to the existing fibula plates in the predicate system, Synthes One-Third Tubular Dynamic Compression Locking plates. The data presented demonstrates substantial equivalence to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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

Howmedica Osteonics Corp. % Ms. Stephanie M. Fitts Director Regulatory 325 Corporate Drive Mahwah, New Jersey 07430

Re: K102282

Trade/Device Name: Variax™ Fibula Straight Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 05, 2010 Received: November 09, 2010

Dear Ms. Fitts:

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.

DEC - 7 2010

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Page 2 - Ms. Stephanie M. Fitts

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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for
Mark N. Melkerson

Mark N. Me 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): K102282

DEC - 7 2010

K102282

Device Name: Variax™ Fibula Straight Plates

Indications For Use:

The VariAx™ Fibula Straight Plates are intended for use in internal fixation of the distal fibula.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

(21 CFR 807 Subpart C)

Over-The-Counter Use

(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

for M. Mulkerson
(Division Signee)

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

510(k) Number K102282