The ORTHOLOC® 3Di Small Bones Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles. The system can be used in both adult and pediatric patients. Examples include:

Metatarsal, metacarpal, or phalangeal fractures and osteotomies
Lesser metatarsal shortening osteotomies (e.g. Weil)
Fifth metatarsal fractures (e.g. Jones Fracture)

Device Description

The ORTHOLOC® 3Di comprises of variety of plates and screws for fixation of bone fragments. The subject device is composed of titanium alloy per ASTM F136. This system consists of plates in left, right, and universal configurations. The plates can feature polyaxial locking holes and compression holes. The plates are provided non-sterile.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) premarket notification for the ORTHOLOC® 3Di Small Bones Plating System, outlining its substantial equivalence to previously marketed devices. It primarily discusses the device's intended use, technological characteristics, and non-clinical and clinical evidence provided for FDA clearance.

The document states:

(b)(1). Substantial Equivalence - Non-Clinical Evidence: "Performance testing and analysis demonstrated substantial equivalence in static and fatigue bending."
(b)(2). Substantial Equivalence Clinical Evidence: "N/A"

This indicates that the clearance was based on non-clinical performance testing against a predicate device, rather than a clinical study with detailed acceptance criteria, ground truth establishment, or human reader performance evaluations as typically seen for AI/software-as-a-medical-device (SaMD) products.

Therefore, I cannot provide the requested table or details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information based on this document.

Summary

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

March 13, 2017

Wright Medical Technology, Inc. Michael Mullins Regulatory Affairs Specialist 1023 Cherry Road Memphis. Tennessee 38117

Re: K163039

Trade/Device Name: ORTHOLOC® 3Di Small Bones Plating System 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: February 17, 2017 Received: February 21, 2017

Dear Mr. Mullins:

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 (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,

Lori A. Wiggins -S

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

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Indications for Use

510(k) Number (if known)

K163039

Device Name ORTHOLOC® 3Di Small Bones Plating System

Indications for Use (Describe)

Metatarsal, metacarpal, or phalangeal fractures and osteotomies
Lesser metatarsal shortening osteotomies (e.g. Weil)
Fifth metatarsal fractures (e.g. Jones Fracture)

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)

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

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1023 Cherry Road Memphis, TN 38117 USA

901 867 9971 800 238 7117 wright.com

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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 Small Bones Plating System.

(a)(1). Submitted By:	Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117
Date:	March 7, 2016
Contact Person:	Michael MullinsRegulatory Affairs SpecialistOffice - (901) 867-4142Fax - (901) 867-4190
(a)(2). Proprietary Name:	ORTHOLOC®3Di SmallBones PlatingSystem
Common Name:	Plate, Fixation, Bone
Classification Name and Reference:	21 CFR 888.3030 - Class II
Device Product Code, Device Panel:	HRS - Orthopedic
(a)(3). Predicate Devices:	Primary: K090692 - ORTHOLOC® 2.0/2.4Reference: K152974 - Crosscheck Plates

(a)(4). Device Description

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(a)(5). INTENDED USE

The ORTHOLOC® 3Di Small Bones Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes. The system can be used in both adult and pediatric patients. Examples include:

Metatarsal, metacarpal, or phalangeal fractures and osteotomies ●
Lesser metatarsal shortening osteotomies (e.g. Weil) ●
Fifth metatarsal fractures (e.g. Jones Fracture)

(a)(6). Technological Characteristics Comparison

The subject ORTHOLOC® 3Di Plating System is technologically substantially equivalent to predicate devices in material and design.

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

Performance testing and analysis demonstrated substantial equivalence in static and fatigue bending.

(b)(2). Substantial Equivalence Clinical Evidence N/A

(b)(3). Substantial Equivalence - Conclusions

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

Regulation Number and Section

§ 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.