ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension

K163650 · Wrightmedicaltechnologyinc · HRS · Apr 24, 2017 · Orthopedic

Device Facts

• Record ID: K163650
• Device Name: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HRS · Orthopedic
• Decision Date: Apr 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ORTHOLOC® 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodessis, in conjuction with osteotomies and fractures of the distal tibia, talus, and calcaneus. ORTHOLOC® Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Device Story

The ORTHOLOC® 3Di Ankle Fusion Plating System is a metallic bone fixation system designed for orthopedic surgical use. The system consists of a titanium alloy Universal Anterior Plate featuring poly-axial locking screw holes and a compression slot, used in conjunction with ORTHOLOC® Bone Screws. The device is implanted by a surgeon during orthopedic procedures to stabilize bone segments, facilitate arthrodesis, or repair fractures. By providing rigid fixation through locking technology, the system maintains bone alignment to promote fusion and healing. The line extension adds specific screw sizes to allow for low-profile fixation in the talus.

Clinical Evidence

No clinical data provided. Substantial equivalence was established via bench testing, specifically finite element analysis and cross-sectional analysis.

Technological Characteristics

Titanium alloy bone fixation plate with poly-axial locking screw holes and compression slot. Utilizes 3Di locking technology. Dimensions and screw sizes vary to accommodate anatomical requirements. Non-powered, mechanical implant.

Indications for Use

Indicated for patients requiring ankle arthrodesis (tibiotalocalcaneal, tibiotalar, or tibiocalcaneal joints) or bone reconstruction, osteotomy, joint fusion, fracture repair, and fixation of the distal tibia, talus, and calcaneus.

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

• ORTHOLOC® 3Di Ankle Fusion Plating System (K121425)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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

April 24, 2017

Wright Medical Technology, Inc. Ms. Rachel Roberts Regulatory Affairs Specialist 1023 Cherry Road Memphis. Tennessee 38117

Re: K163650

Trade/Device Name: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: March 16, 2017 Received: March 20, 2017

Dear Ms. Roberts:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mark N. Melkerson -S

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

Enclosure

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

## 510(k) Number (if known)

K163650

## Device Name

ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension

## Indications for Use (Describe)

The ORTHOLOC® 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodessis, in conjuction with osteotomies of the distal tibia, talus, and calcaneus.

ORTHOLOC® Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Headquarters Wright Medical Technology, Inc.

1023 Cherry Road Memphis, TN 38117

901 867 9971 wmt.com

Image /page/3/Picture/3 description: The image contains the logo for Wright. The logo has a red and orange geometric shape on the left, followed by the word "WRIGHT" in red, and the words "FOCUSED EXCELLENCE" in gray below. The geometric shape is made up of two overlapping trapezoids, one red and one orange.

# K163650 510(K) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the ORTHOLOC® 3Di Ankle Fusion Plating System - Line Extension.

| (a)(1). Submitted By: | Wright Medical Technology, Inc.<br>1023 Cherry Road<br>Memphis, TN 38117 |
|------------------------------------|----------------------------------------------------------------------------------------------------|
| Date: | March 17, 2017 |
| Contact Person: | Rachel Roberts<br>Regulatory Affairs Specialist<br>Office - [phone]<br>Fax - [phone] |
| (a)(2). Proprietary Name: | ORTHOLOC® 3Di Ankle Fusion Plating System –<br>Line Extension |
| Common Name: | Plate, Fixation, Bone<br>Screw, Fixation, Bone |
| Classification Name and Reference: | 21 CFR 888.3030 - Class II<br>21 CFR 888.3040 - Class II |
| Device Product Code, Device Panel: | HRS - Orthopedic<br>HWC - Orthopedic |
| (a)(3). Predicate Device: | K121425: ORTHOLOC® 3Di Ankle Fusion Plating<br>System |

# (a)(4). Device Description

The subject Universal Anterior Plate is designed to facilitate arthrodesis of the ankle and is composed of titanium alloy. The plate features poly-axial locking screw holes and one compression slot. It accepts screws of multiple diameters and lengths.

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## K163650

## (a)(5). INTENDED USE

The ORTHOLOC® 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodessis, in conjuction with osteotomies and fractures of the distal tibia, talus, and calcaneus.

ORTHOLOC® Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

## (a)(6). Technological Characteristics Comparison

The subject ORTHOLOC 3Di Universal Anterior Plate is substantially equivalent to the predicate devices in materials and design. The plate incorporated the predicate 3Di locking technology with an additional size of screws which allow for low profile fixation in the talus.

## (b)(1). Substantial Equivalence - Non-Clinical Evidence

Finite element analysis and cross-sectional analysis demonstrated substantial equivalence. Through this testing it was determined that the addition of the Universal Anterior Plate is substantially equivalent in bending strength to the predicate and does not introduce a new worse case into the system.

## (b)(2). Substantial Equivalence - Clinical Evidence

N/A

#### (b)(3). Substantial Equivalence - Conclusions

The design characteristics of the subject plate do not raise any new types of questions of safety of effectiveness. From the evidence submitted in this 510(k), the subject device can be expected to perform at least as well as the predicate.