Wright's ORTHOLOC™ 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodeses, in conjunction 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 Description

ORTHOLOC™ 3Di Ankle Fusion Plating System: The ORTHOLOC™ 3Di Ankle Fusion Plating System contains 22 plates belonging to 1 of 3 general categories based on the contouring of each plate and intended surgical approach. All plates feature poly-axial locking screw holes and one or two compression slots. The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3 and accept 4.5mm and 5.5mm ORTHOLOC™ 3Di locking screws, 4.5mm and 5.5mm ORTHOLOC™ Fully Threaded Bone Screws, and 5.5mm ORTHOLOC™ Partially-Threaded Bone Screws. Washers of the same material are also available for use with the ORTHOLOC™ Bone Screws.

ORTHOLOC™ Bone Screws: ORTHOLOCTM Bone Screws are cancellous or cortical, partially or fully threaded non-locking screws offered in various diameters and lengths. All screws are manufactured from ASTM F136 or ISO 5832-3 titanium alloy and intended for single use only. These screws are intended to be used with the appropriately sized washers to prevent the screw head from breaking through the cortex of the bone by distributing the forces/loads over a large area.

AI/ML Overview

The provided document, K121425 for the ORTHOLOC™ 3Di Ankle Fusion Plating System and ORTHOLOCTM Bone Screws, describes non-clinical evidence for substantial equivalence, primarily focusing on mechanical testing rather than a clinical study or AI-based performance. Therefore, many of the requested elements for AI-based device evaluation (like sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance with AI) are not applicable or not explicitly detailed in this 510(k) summary.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Polyaxial Locking Feature Effectiveness (Mechanical)	Acceptable for off-axis mechanical screw locking up to 3x as compared to a non-locking screw. (This implies it met pre-defined mechanical performance thresholds for successful locking at angles).
Screw Torque / Pullout Resistance	Results exceeded the pre-determined acceptance criteria. (Specific numerical values for acceptance criteria or results are not provided).
Stress Response of Plates (Worst-case)	Found to be similar to a predicate plate through mechanical engineering analysis. (This implies the stress distribution and magnitude under load were comparable and acceptable relative to an already cleared device).

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

Test Set Sample Size: Not explicitly stated as this was mechanical testing of device components, not a clinical study on patient data.
Data Provenance: The data is generated from in vitro mechanical testing of the physical device components (plates and screws). There is no patient data involved from specific countries or retrospective/prospective studies.

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

Not Applicable. This submission relies on engineering and mechanical testing, not a ground truth established by human experts interpreting clinical data for diagnosis or treatment decisions. The "ground truth" or acceptance criteria for mechanical properties would be established by engineering standards and internal specifications, likely vetted by qualified engineers.

4. Adjudication Method for the Test Set:

Not Applicable. As this is mechanical testing, there is no human interpretation of images or clinical data that would require an adjudication method. The results are quantitative measurements against pre-defined engineering thresholds.

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

No. An MRMC study was not done. This submission is for a medical implant (bone plates and screws) and primarily relies on mechanical performance testing for substantial equivalence, not on the interpretation capabilities of human readers, with or without AI assistance.

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

Not Applicable. This is not an AI algorithm. The device is a physical surgical implant.

7. The Type of Ground Truth Used:

The "ground truth" for the mechanical performance testing would be the established engineering specifications, ASTM or ISO standards, and internal design requirements for strength, locking mechanism efficacy, and pullout resistance for bone plates and screws. These are quantifiable, objective physical properties.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI device, so there is no "training set."

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

Not Applicable. As there is no training set for an AI algorithm, this question does not apply.

Summary

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K121425 '

1 2012

510(K) SUMMARY 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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the ORTHOLOC™ 3Di Ankle Fusion Plating System.

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Device Product Code, Device Panel:

1. Predicate Devices:
  Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002

August 6, 2012

Samir Ibrahim, PhD, RAC Regulatory Affairs Specialist II (901) 290-5909

ORTHOLOC™ 3Di Ankle Fusion Plating System and ORTHOLOCTM Bone Screws

Bone Plate System Screw, Fixation, Bone

21 CFR 888.3030 - Class II 21 CFR 888.3040 - Class II

HRS: Orthopedic HWC: Orthopedic

K110670 -PERI-LOC Ankle Fusion Bone Plates
K100176 -Ascension® Ankle Fusion Plate System
K090139 -Torrier® Stabilis™ Ankle Arthrodesis Plate System
K073375 -Integra® / Newdeal® Tibiazys™ System
Newdeal® Advansys™ TTC Plate K060473 -

K061940 -Synthes® LCP Ankle Arthrdesis Plates

K112772 -ORTHOLOCTM Bone Screws

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4. Device Description

5. Intended Use

ORTHOLOC™ 3Di Ankle Fusion Plating System: Wright's ORTHOLOCTM 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodeses, in conjunction with osteotomies and fractures of the distal tibia, talus, and calcaneus.

ORTHOLOC™ Bone Screws: 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.

Technological Characteristics Comparison 6.

ORTHOLOC™ 3Di Ankle Fusion Plating System: Based on a technical feature comparison, the subject device was found to be similar to all predicate devices with regard to design and materials. The subject plates also have a polyaxial locking feature that offers locking up to 15° off-axis, similar to the design used in ORTHOLOC™ 3Di Ankle Plating System (K102429).

ORTHOLOC™ Bone Screws: Two larger screw sizes are being added to the ORTHOLOC™ Bone Screw system. They share similar head, neck, and thread designs as the smaller screws that are currently cleared under K112772. These implants are available in the following size ranges:

Device	Diameters (mm)	Lengths (mm)
Non-Locking Fully Threaded	4.5-5.5	15-65
Non-Locking Partially Threaded	5.5	55-100

7. Substantial Equivalence - Non-Clinical Evidence

The indication statements of both the subject and predicates devices convey the same intended use and literature was provided to support the safe and effective use of plate/screw systems for fusing the ankle. Performance testing supports the effectiveness of the polyaxial

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locking feature, screw torque / pullout resistance, and stress response of the plates. The subject plate locking mechanism evaluated in this testing was found to be acceptable for offaxis mechanical screw locking up to 3x as compared to a non-locking screw. Torque and pullout testing was performed and the results exceeded the pre-determined acceptance criteria. Additionally through mechanical engineering analysis, the stress response of the worst-case plate was found to be similar to a predicate plate.

Substantial Equivalence - Clinical Evidence 8.

N/A

Substantial Equivalence - Conclusions 9.

The design characteristics and surgical approach of the subject system do not raise any new types of questions of safety or effectiveness. Performance testing supports the effectiveness of the polyaxial locking feature, screw insertion / pullout resistance, and stress response of the plates. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol.

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

OCT
1 2012

Wright Medical Technology, Inc. % Samir Ibrahim, Ph.D. 5677 Airline Road Arlington, TN 38002

Re: K121425

Trade/Device Name: ORTHOLOC 3Di Ankle Fusion Plating System and ORTHOLOC Bone Screws

Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

CH. 11

Regulatory Class: II Product Code: HRS, HWC Dated: September 18, 2012 Received: September 19, 2012

Dear Dr. Ibrahim:

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

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Page 2 - Samir Ibrahim, Ph.D.

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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. Miller

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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Traditional 510(k) ORTHOLOCTN 3Di Ankle Fusion Plating System Wright Medical Technology, Inc.

INDICATIONS FOR USE STATEMENT

K121425 510(k) Number:

Device Name:

ORTHOLOC™ 3Di Ankle Fusion Plating System and ORTHOLOC™ Bone Screws

Indications For Use:

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.

Ads

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Division of Surgical, Orthopedic, and Restorative Devices

×121425 510(k) Number

Prescription Use (Per21 CFR 801.109) OR

Over-The Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.