(122 days)
Not Found
No
The 510(k) summary describes a mechanical plating system for ankle fusion and bone screws. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are based on finite element analysis and cross-sectional analysis, which are traditional engineering methods, not AI/ML.
Yes
The device is described as an "Ankle Fusion Plating System" intended to "facilitate arthrodesis of the ankle" and "bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation," all of which are therapeutic interventions.
No
The device is a plating system and bone screws intended to facilitate arthrodesis and fracture repair, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states the device is a "Universal Anterior Plate" composed of "titanium alloy," which is a hardware component. The intended use also describes a "Plating System" and "Bone Screws," further indicating hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text describes a surgical implant (a bone plate and screws) used to facilitate the fusion of ankle bones. This is a physical device used in vivo (within the body) during surgery, not a test performed on a sample in vitro (outside the body).
The device's purpose is to provide structural support and stability to the ankle bones to promote fusion, which is a surgical procedure, not a diagnostic test.
N/A
Intended Use / Indications for 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 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.
Product codes
HRS, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodessis, distal tibia, talus, and calcaneus.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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.
1023 Cherry Road
Memphis, TN 38117 |
|------------------------------------|----------------------------------------------------------------------------------------------------|
| Date: | March 17, 2017 |
| Contact Person: | Rachel Roberts
Regulatory Affairs Specialist
Office - (901) 867-9708
Fax - (901) 867-4190 |
| (a)(2). Proprietary Name: | ORTHOLOC® 3Di Ankle Fusion Plating System –
Line Extension |
| Common Name: | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Classification Name and Reference: | 21 CFR 888.3030 - Class II
21 CFR 888.3040 - Class II |
| Device Product Code, Device Panel: | HRS - Orthopedic
HWC - Orthopedic |
| (a)(3). Predicate Device: | K121425: ORTHOLOC® 3Di Ankle Fusion Plating
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.