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 Malleolous
Pilon Fractures
Distal Tibia Shaft Fractures
Distal Fibula Shaft Fractures
Distal Tibia Periarticular Fractures
Medial Malleolar Avulsion Fractures
Lateral Malleolar Avusion Fractures

The 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 contains 45 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. Some plates have k-wire holes, compression slots, or syndesmosis slots. The plates are made from titanium alloy and accept 2.7mm and 3.5mm ORTHOLOC™ 3Di locking screws, 3.5mm and 4.0mm ORTHOLOC™ Bone Screws, and 4.0mm Wright™ Compression Screws (cleared under K082320, now branded DART-FIRE®). Washers are also available for use with the ORTHOLOC™ Bone Screws.

AI/ML Overview

The provided document, K102429, describes a 510(k) premarket notification for the ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove effectiveness or safety by meeting specific performance criteria.

Therefore, the document does not contain information typically associated with acceptance criteria and a study proving a device meets them in the context of diagnostic or AI-driven devices. Instead, it relies on non-clinical (bench) testing to show that the new device performs "at least as well as" the predicate device in relevant mechanical performance aspects.

Here's an analysis based on the provided text, addressing the requested points where applicable, and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical medical device, "acceptance criteria" are typically related to engineering and material performance rather than diagnostic accuracy metrics like sensitivity or specificity. The document states that substantial equivalence is shown through various mechanical tests.

Acceptance Criteria (Demonstration of Equivalence to Predicate)	Reported Device Performance
Worst-case plate analysis torque to failure	"The results of the test show that the subject ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws can be expected to perform at least as well as the legally marketed predicate ORTHOLOC™ APS and Wright Compression Screws." Specific numerical values for the torque to failure are not provided in this summary, but the conclusion is that equivalence was demonstrated.
Polyaxial performance	"The results of the test show that the subject ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws can be expected to perform at least as well as the legally marketed predicate ORTHOLOC™ APS and Wright Compression Screws." Specific numerical values are not provided, but the conclusion is that equivalence was demonstrated.
Torsional testing	"The results of the test show that the subject ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws can be expected to perform at least as well as the legally marketed predicate ORTHOLOC™ APS and Wright Compression Screws." Specific numerical values are not provided, but the conclusion is that equivalence was demonstrated.
Pull out/pull through testing	"The results of the test show that the subject ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws can be expected to perform at least as well as the legally marketed predicate ORTHOLOC™ APS and Wright Compression Screws." Specific numerical values are not provided, but the conclusion is that equivalence was demonstrated. The text explicitly states, "Substantial equivalence is shown through worst-case plate analysis torque to failure, polyaxial performance, torisional, and pull out/pull through testing." and "No new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices."

2. Sample Size Used for the Test Set and the Data Provenance

This document describes non-clinical (bench) testing, not a clinical study with patients or data. Therefore, the concept of "sample size for the test set" in the context of clinical data, or data provenance (country of origin, retrospective/prospective) is not applicable here. The "test set" would refer to the physical devices (plates and screws) subjected to mechanical testing. The specific number of devices tested is not detailed in this summary, but implied by the successful completion of the stated tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. Ground truth, in the sense of clinical diagnoses or pathology, is not relevant for this type of mechanical device submission and the non-clinical testing performed.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of clinical data requiring expert adjudication. The "adjudication" for this type of device would be the interpretation of the results from the mechanical tests, likely by engineers and materials scientists.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is a clinical study typically used for diagnostic devices to assess how human readers perform with and without AI assistance. This submission is for a mechanical fixation device and relies on non-clinical bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This is not an AI algorithm or diagnostic device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering standards and established mechanical testing protocols that define the performance characteristics of orthopedic fixation devices. The goal is to demonstrate that the new device meets these engineering benchmarks at least as well as its predicate.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI model, ground truth for it was not established.

Summary

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K102429 PG. 1/3

510(K) SUMMARY NOV 2 3 2010 OF SAFETY AND EFFECTIVENESS

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 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the URTHOLOC™ 3Di Ankle Plating System and ORTHOLOCTM Bone Screws.

A.1. Submitted By:

Date:

Contact Person:

5677 Airline Rd Arlington, TN 38002

August 13, 2010

Megan McCagh, RAC

Regulatory Affairs Specialist

ORTHOLOCTM Bone Screws

Wright Medical Technology, Inc.

(901) 867-4120

A.2. Proprietary Name:

Common Name:

Device Classification Regulation:

Device Product Code & Panel:

A.3. Predicate Device:

Bone Plate System

21 CFR 888.3030-Class II

21 CFR 888.3040-Class II

HRS: Plate, Fixation Bone

HWC: Screw, Fixation Bone

87 Orthopedics

K091243-ORTHOLOC™ Ankle Plating System K082320-WrightTM Compression Screws

ORTHOLOCTM 3Di Ankle Plating System and

A.4. Device Description

The design features of the ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws are substantially equivalent to the design features of the predicate ORTHOLOC™ APS and Wright™ Compression Screws.

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A.S. Intended Use

Ankle Plates:

Wright's ORTHOLOC™ 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 Malleolous t
Pilon Fractures t
Distal Tibia Shaft Fractures .
Distal Fibula Shaft Fractures t
Distal Tibia Periarticular Fractures .
Medial Malleolar Avulsion Fractures .
Lateral Malleolar Avusion Fractures .

ORTHOLOC™ 3D iLocking Screws:

The ORTHOLOCTM 3Di locking screws are intended for use with Wright's ORTHOLOCTM 3Di Plating Systems of the same base material.

ORTHOLOCTM Bone Screws:

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

Washer

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 ORTHOLOCTM 3Di Ankle Plating System and the legally marketed predicate ORTHOLOC™ APS have similar indications, utilize similar instrumentation, and are identical in material, anatomical design and selection. The subject ORTHOLOC™ 3Di Ankle Plates have been modified to reduce the excess material and accommodate surgeon feedback. ORTHOLOCTM bone screws are identical in indications for use, diameter, and material and are included in the size range of the legally marketed predicate. Wright™ Compression Screws. The subject screws differ in thread pitch and form, and driver type.

B.1. Substantial Equivalence - Non-Clinical Evidence

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Substantial equivalence is shown through worst-case plate analysis torque to failure, polyaxial performance, torisional, and pull out/pull through testing. The results of the test show that the subject ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws can be expected to perform at least as well as the legally marketed predicate ORTHOLOCTM APS and Wright Compression Screws.

The safety and effectiveness of the subject ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within the Premarket Notification.

B.2. Substantial Equivalence - Clinical Evidence

N/A

B.3. Substantial Equivalence - Conclusions

Substantial equivalence is shown through worst-case plate analysis and torque to failure, polyaxial performance, torisional, and pull out/pull through testing. The subject plates are identical to the predicate plates in material, anatomical design and selection, and thickness materials, and similar in indications, and instrumentation utilized. The subject plates have been modified to accept the modified predicate screws with a smaller distal pitch. The subject screws are identical in indication for use, diameter, size range and material to the predicate, and differ in thread pitch and form and driver type. No new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance. The overall design is simple and recognizable, representing the department's role in public health and human services.

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

Wright Medical Technology, Inc. % Ms. Megan McCagh, RAC Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

NOV 2 3 2010

Re: K102429

Trade/Device Name: ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and appliances Regulatory Class: II Product Code: HRS, HWC Dated: August 24, 2010 Received: August 25, 2010

Dear Ms. McCagh:

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, Drig 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 of edisons 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

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Page 2 - Ms. Megan McCagh, RAC

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark A. Milken

Mark N. Melkerson 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):

NOV 2 3 2010

Device Name: ORTHOLOC™ 3Di Ankle Plating System

Indications For Use:

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 Malleolous .
Pilon Fractures .
. Distal Tibia Shaft Fractures
Distal Fibula Shaft Fractures .
Distal Tibia Periarticular Fractures .
Medial Malleolar Avulsion Fractures .
Lateral Malleolar Avusion Fractures .

The 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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K102429

Concurrence of CDRH, Office of Device Evaluation (ODE)

. ··

Soutu for nxm
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

2017

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.