Wright's ORTHOLOC® 3Di Ankle Fracture Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:

Lateral Malleolar Fractures ●
Syndesmosis Injuries
Medial Malleolar Fractures
Bi-Malleolar Fractures
Tri-Malleolar Fractures
Posterior Malleolar Fractures
Distal Anterior Tibia Fractures
Vertical Shear Fractures of the Medial Malleolus
Pilon Fractures
Distal Tibia Shaft Fractures
Distal Fibula Shaft Fractures
Distal Tibia Periarticular Fractures
Medial Malleolar Avulsion Fractures
Lateral Malleolar Avulsion Fractures

ORTHOLOC® 3Di Locking Screws are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.

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.

Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

Device Description

The ORTHOLOC® 3Di Ankle Plating System consists of plates belonging to 1 of 2 general categories-distal tibia and fibula-based on the contouring of each plate. All plates feature poly-axial locking screw holes while some plates feature compression slots. The plates are made from titanium alloy and are compatible with 2.7mm and 3.5mm ORTHOLOC® 3Di locking screws, 3.5mm and 4.0mm ORTHOLOC® Bone Screws, and 4.0mm Wright Compression Screws.

AI/ML Overview

The provided text is a 510(k) summary for the ORTHOLOC® 3Di Ankle Fracture Plating System. This document focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as understood in the context of clinical performance of an AI/Software as a Medical Device (SaMD).

Instead, the submission relies on demonstrating substantial equivalence through non-clinical performance testing and engineering analysis of the physical components (plates, screws, washers) against legally marketed predicate devices.

Here's an analysis of the information provided in relation to your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria for Substantial Equivalence (Implicit): The implicit acceptance criterion is that the subject device's performance characteristics (e.g., static and fatigue bending strength, insertion/removal torque, pull-out strength, torsional strength) are "at least as well as" or "substantially equivalent" to the predicate devices.
Reported Device Performance: The document states that "Performance testing, engineering analysis and rationale was performed to demonstrate substantial equivalence in static and fatigue bending strength." It also mentions "An engineering analysis was performed for the subject device screws to demonstrate substantial equivalence with respect to insertion/removal torque, pull-out strength and torsional strength, and bending strength."
Missing Specifics: The actual numerical acceptance values (e.g., minimum bending strength in Nm) and the corresponding test results for the ORTHOLOC® 3Di Ankle Fracture Plating System are not provided in this summary document. These would typically be in the full 510(k) submission, but only the conclusion is summarized here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable in this context: Since this is a physical medical device (bone plating system) being evaluated for substantial equivalence through non-clinical (mechanical) testing, terms like "test set," "data provenance," "country of origin," "retrospective," or "prospective" are not relevant. The "sample size" would refer to the number of physical devices tested in the engineering lab, but this detail is not present in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: This type of information is relevant for AI/SaMD where human expert consensus is used to establish ground truth for diagnostic or prognostic tasks. For a bone plating system, ground truth is established by objective engineering principles and measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: Adjudication methods are used to resolve disagreements among human experts in clinical studies, particularly for AI/SaMD. This is not relevant for the mechanical testing of a surgical implant.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: MRMC studies are used to evaluate the performance of diagnostic tools, often imaging-based AI solutions, and their effect on human reader performance. This device is a surgical implant, not a diagnostic tool, and there is no AI component mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable: This question pertains to AI/SaMD performance. The ORTHOLOC® 3Di Ankle Fracture Plating System is a physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Engineering Standards/Measurements: The "ground truth" for the non-clinical tests would be established by universally accepted engineering standards and validated measurement techniques for properties like strength, torque, and pull-out resistance. The predicate devices serve as the benchmark for "acceptable" performance.

8. The sample size for the training set

Not Applicable: This concept relates to machine learning models (AI). There is no "training set" for a physical medical device like this, which is evaluated through mechanical testing.

9. How the ground truth for the training set was established

Not Applicable: As there is no training set, this question is not relevant.

In summary:

This 510(k) document demonstrates substantial equivalence through non-clinical performance testing and engineering analysis of the physical hardware (plates, screws, washers). It explicitly states:

(b)(1). Substantial Equivalence - Non-Clinical Evidence: "Performance testing, engineering analysis and rationale was performed to demonstrate substantial equivalence in static and fatigue bending strength. An engineering analysis was performed for the subject device screws to demonstrate substantial equivalence with respect to insertion/removal torque, pull-out strength and torsional strength, and bending strength."
(b)(2). Substantial Equivalence - Clinical Evidence: "N/A" (Not Applicable), indicating no clinical studies were performed to establish effectiveness for this submission.
(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 devices."

The study that "proves the device meets the acceptance criteria" is the non-clinical performance testing and engineering analysis comparing the ORTHOLOC® 3Di Ankle Fracture Plating System to its predicate devices, showing "substantial equivalence" in mechanical properties. Specific numerical details of these tests are not provided in this summary.

Summary

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

Janaury 26, 2017

Wright Medical Technology, Inc. Val Myles Regulatory Affairs Specialist 1023 Cherry Road Memphis. TN 38117

Re: K163044 Trade/Device Name: ORTHOLOC® 3Di Ankle Fracture 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, HWC Dated: October 21, 2016 Received: October 31, 2016

Dear Ms. Val Myles:

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,

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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Indications for Use

510(k) Number (if known)

K163044

Device Name

ORTHOLOC® 3Di Ankle Fracture Plating System

Indications for Use (Describe)

Wright's ORTHOLOC® 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:

Lateral Malleolar Fractures
· Syndesmosis Injuries
Medial Malleolar Fractures
Bi-Malleolar Fractures
· Tri-Malleolar Fractures
Posterior Malleolar Fractures
Distal Anterior Tibia Fractures
Vertical Shear Fractures of the Medial Malleolus
· Pilon Fractures
Distal Tibia Shaft Fractures
· Distal Fibula Shaft Fractures
Distal Tibia Periarticular Fractures
Medial Malleolar Avulsion Fractures
· Lateral Malleolar Avulsion Fractures

ORTHOLOC® 3Di Locking Screws are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.

ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, orthrodesis, joint fusion, fracture repar, and fracture fixation, appropriate for the size of the device.

Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

Type of Use (Select one or both, as applicable)
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|× 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 mt.com

K163044

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 Fracture Plating System.

Wright Medical Technology, Inc. (a)(1). Submitted By:

	1023 Cherry RoadMemphis, TN 38117
Date:	October 21, 2016
Contact Person:	Val MylesRegulatory Affairs SpecialistOffice - (901) 290-5162Fax - (901) 867-4190
(a)(2). Proprietary Name:	ORTHOLOC® 3Di Ankle Fracture Plating System
Common Name:	Plate, Fixation, BoneScrew, Fixation, Bone
Classification Name and Reference:	21 CFR 888.3030 - Class II21 CFR 888.3040 - Class II
Device Product Code, Device Panel:	HRS - OrthopedicHWC - Orthopedic
(a)(3). Predicate Device:	ORTHOLOC® 3Di Ankle Fracture: K131093 K102429Synthes LCP Distal Fibula Plates: K073460Synthes Small Fragment DCL: K000684

(a)(4). Device Description

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K163044

(a)(5). INTENDED USE

Wright's ORTHOLOC® 3Di Ankle Fracture Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:

Lateral Malleolar Fractures ●
Syndesmosis Injuries
Medial Malleolar Fractures
Bi-Malleolar Fractures
Tri-Malleolar Fractures
Posterior Malleolar Fractures
Distal Anterior Tibia Fractures
Vertical Shear Fractures of the Medial Malleolus
Pilon Fractures
Distal Tibia Shaft Fractures
Distal Fibula Shaft Fractures
Distal Tibia Periarticular Fractures
Medial Malleolar Avulsion Fractures
Lateral Malleolar Avulsion Fractures

ORTHOLOC® 3Di Locking Screws are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.

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.

Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

(a)(6). Technological Characteristics Comparison

The subject devices included in ORTHOLOC® 3Di Ankle Fracture Plating System are technologically substantially equivalent to predicate devices in material, size, and bending strength.

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

Performance testing, engineering analysis and rationale was performed to demonstrate substantial equivalence in static and fatigue bending strength. An engineering analysis was performed for the subject device screws to demonstrate substantial equivalence with respect to insertion/removal torque, pull-out strength and torsional strength, and bending strength.

(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 devices.

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.