Wright's ORTHOLOC® Calcaneal Plating System is intended for use in stabilization of fresh fractures, jount fusion and reconstruction of bones in the feet and ankles. The system can be used in both adult and pediatric patients.

Device Description

The ORTHOLOC® Calcaneal Plating System consists of 2 styles of plates (Tab and Perimeter) and features 3.5mm diameter locking and non-locking screws that range from 10-60mm each. The Tab plates are offered in three different sizes: small, medium, and large, and feature multiple tabs that can be manipulated or cut to accommodate for various patient anatomy. The Perimeter plates come in two sizes: small and large and also feature removable sections. The ORTHOLOC® hole design on the plates allow for the screws to be inserted from either side. This allows each plate to be used in either a right or a left orientation.

AI/ML Overview

The provided document is a 510(k) summary for the ORTHOLOC® Calcaneal Plating System. This is a medical device submission to the FDA, not a study evaluating an AI device or a diagnostic tool that would typically have acceptance criteria in terms of performance metrics like sensitivity or specificity.

Instead, this document focuses on demonstrating substantial equivalence to a previously approved predicate device. The "acceptance criteria" here are related to fulfilling the requirements for substantial equivalence to warrant market clearance.

Here's an breakdown based on the information provided, framed as closely as possible to your request, but acknowledging the nature of this document:

1. Table of "Acceptance Criteria" (for 510(k) clearance) and Reported Device Performance (as presented for substantial equivalence):

"Acceptance Criteria" (FDA 510(k) Requirements for Substantial Equivalence)	Reported Device Performance (as evidence for substantial equivalence)
Material Strength (Equivalent or superior to predicate)	Made of stronger material than the predicate device.
Mechanical Performance (Static Bend Testing) (Equivalent or superior)	Performance shown to be statistically equivalent or greater than the predicate system.
Mechanical Performance (Screw through Plate Testing) (Equivalent or superior)	Performance shown to be statistically equivalent or greater than the predicate system.
Intended Use (Similar to predicate, no new questions of safety/effectiveness)	Similar intended use for stabilization of fractures, joint fusion, and reconstruction of bones in feet and ankles for adult and pediatric patients. (Compared against predicate with "limited indications" - implying the subject device's indications are at least covered by, or a subset of, the predicate's).
Technological Characteristics (Similar to predicate)	Utilizes similar instrumentation, similar sterilization methods. Key differences (e.g., stronger material, different plate styles) addressed.

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

Test Set (for mechanical testing): Not explicitly stated in the provided text. The document mentions "Mechanical testing, including Static Bend Testing and Screw through Plate testing," but does not specify the number of samples tested for each.
Data Provenance: The mechanical testing was likely conducted in a lab setting by the manufacturer (Wright Medical Technology, Inc.), not from human or animal data.

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

Not Applicable (N/A). This is a mechanical device, and "ground truth" as typically defined for diagnostic or AI studies (e.g., by expert consensus on images) is not relevant here. The "ground truth" for mechanical testing is established by engineering principles and standardized test methods.

4. Adjudication Method:

N/A. Adjudication is not applicable to mechanical testing in this context. The results of the mechanical tests (e.g., load to failure, displacement) are quantitative and directly measured.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is a hardware device (bone plating system), not a diagnostic or AI system. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance:

No. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used:

Engineering Standards and Benchmarking: The "ground truth" for the performance of this device is based on established engineering test standards (e.g., ASTM or ISO standards for bone plates) and comparison to the mechanical properties of the legally marketed predicate device.

8. Sample Size for the Training Set:

N/A. This is a physical medical device, not an AI or machine learning system that requires a "training set" in the computational sense. The design and manufacturing process would involve engineering specifications, and prototypes would be tested, but not in the context of an AI training set.

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

N/A. As above, the concept of a training set and its associated ground truth isn't applicable to this type of device. The design specifications and performance targets are derived from medical requirements, biomechanical principles, and regulatory standards.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

August 21, 2014

Wright Medical Technology, Inc. Ms. Jeanine Redden Director, Regulatory Affairs 1023 Cherry Road Memphis, Tennessee 38117

Re: K142121 Trade/Device Name: ORTHOLOC® Calcaneal 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: July 31, 2014 Received: August 4, 2014

Dear Ms. Jeanine Redden:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Jeanine Redden

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 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/Resourcesfor You/Industry/default.htm. 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 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 vours.

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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K142121

umber (if known)

510(k) Number (if known)

Device Name

ORTHOLOC® Calcaneal Plating System

Indications for Use (Describe)

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

01 867.9971 vmt.com

Image /page/3/Picture/3 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, to the left of the word "WRIGHT" in red. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, lighter font. The logo is clean and modern, with a focus on the company name.

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® Calcaneal Plating System.

1.	Submitted By:	Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
	Date:	August 12, 2014
	Contact Person:	Jeanine Redden Director, Regulatory Affairs Phone: 901.867.4255 Fax: 901.687.4190
2.	Proprietary Name:	ORTHOLOC® Calcaneal Plating System
	Common Name:	Plate, Fixation, Bone
	Classification Name and Reference:	21 CFR 888.3030- Class II, Single/multiple component metallic bone fixation appliances and accessories
	Device Product Code, Device Panel:	HRS - Orthopedic
3.	Predicate Device:	K061808 DARCO® Locking Bone Plate System K091243 ORTHOLOC® Ankle Plating System

4. Device Description

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5. Intended Use

Wright's ORTHOLOC® Calcaneal Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones in the feet and ankles. The system can be used in both adult and pediatric patients.

6. Technological Characteristics Comparison

The ORTHOLOC® Calcaneal Plating System compared the legally marketed predicate device has limited indications, utilizes similar instrumentation, is made of stronger material, and has identical sterilization methods.

7. Substantial Equivalence- Non-Clinical Evidence

Mechanical testing, including Static Bend Testing and Screw through Plate testing, has shown that the performance of the subject plating system is statistically equivalent or greater than the predicate plating system.

8. Substantial Equivalence- Clinical Evidence

N/A

9. Substantial Equivalence- Conclusions

The design characteristics of the subject devices 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 systems and are substantially equivalent.

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.