The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

Device Description

The subject device plates are provided in a variety of anatomical designs, in various lengths, widths and thicknesses. The plate thickness varies from 1.6 mm to 2.0 mm depending on the design. The screw holes of the subject device plates are designed to accommodate appropriately sized subject device screws, or screws presently marketed as part of the APTUS System and previously cleared under K091479. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are used with TriLock locking screws and cortical (nonlocking) screws. All subject device screws are self-tapping and self-drilling and provided in diameters of 2.0, 2.8 and 3.5 mm, and in various lengths from 8 to 45 mm.

The subject device plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The subject device screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

AI/ML Overview

This document is a 510(k) Premarket Notification from Medartis AG for their APTUS® Foot System. It aims to demonstrate substantial equivalence to previously marketed devices. While it describes performance data, it does not explicitly define acceptance criteria as a standalone statement with pass/fail thresholds. Instead, the "performance data" section outlines the types of testing conducted to support substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit acceptance criteria are not provided, I will infer them based on the types of tests conducted and the general objective of demonstrating substantial equivalence to predicate devices regarding safety and effectiveness. The reported device performance is based on the information provided in the "PERFORMANCE DATA" section.

Acceptance Criteria (Inferred from testing)	Reported Device Performance (Summary)
Dimensional Analysis: Conformity to specified dimensions for plates and screws.	Conducted to demonstrate substantial equivalence; implies conformity.
Engineering Analysis: Structural integrity and design parameters.	Conducted to demonstrate substantial equivalence; implies acceptable engineering.
Finite Element Analysis (FEA): Simulation of stress, strain, and deformation under load.	Conducted to demonstrate substantial equivalence; implies acceptable mechanical behavior.
Mechanical Testing:
* ASTM F543 - Metallic Bone Screws Test Methods:
* Insertion Torque: Acceptable torque for screw insertion.	Tested (subject and predicate screws).
* Maximum Torque: Acceptable maximum torque before failure.	Tested (subject and predicate screws).
* Pull-Out Testing: Sufficient resistance to pull-out forces.	Tested (subject and predicate screws).
* Dynamic Mechanical Testing: Acceptable fatigue strength and durability for plate designs.	Tested (subject and predicate plate designs).

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

Sample Size: Not explicitly stated for any of the tests. The document only mentions "subject device screws were tested" and "Dynamic mechanical testing of the subject and predicate plate designs also was performed."
Data Provenance: Not explicitly stated. The tests were performed to support a 510(k) submission for a device manufactured by Medartis AG, located in Basel, Switzerland. The data would have been generated as part of their product development and regulatory submission process. It is generally retrospective for the purpose of a 510(k) submission, meaning the tests were conducted on pre-market devices to gather data for equivalence.

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

Not Applicable. This submission does not involve a clinical study or a judgmental process requiring expert consensus on a test set (e.g., image interpretation). The "ground truth" for the mechanical and engineering performance data is established by the results of the standardized tests (e.g., ASTM F543) themselves and the comparative analysis against predicate devices.

4. Adjudication Method for the Test Set:

Not Applicable. No human adjudication method was described as the performance data consisted of dimensional, engineering, finite element analysis, and mechanical testing, not clinical outcomes requiring expert review.

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

No. An MRMC comparative effectiveness study was not done. This submission focuses on the mechanical and design equivalence of a bone fixation system, not on an algorithm or imaging device that would typically involve human readers.

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

Not Applicable. This device is a bone fixation system, not a software algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on engineering standards, material specifications, and objective mechanical test results. For example:
- ASTM F67 for commercially pure titanium (plates).
- ASTM F136 for titanium alloy (screws).
- ASTM F543 for metallic bone screws test methods (insertion torque, maximum torque, pull-out).
- Comparison to the performance of legally marketed predicate devices (K091479, K071264, K100776, K090949, K101700).

8. The Sample Size for the Training Set:

Not Applicable. This submission is for a physical medical device (bone fixation system), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not Applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply here.

Summary

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

Medartis AG % Mr. Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

April 9, 2015

Re: K142581 Trade/Device Name: APTUS® Foot 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: March, 4 2015 Received: March 6, 2015

Dear Mr. Thomas:

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

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Page 2 - Mr. Kevin A. Thomas

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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/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 yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known) K142581

Device Name

APTUS® Foot System

Indications for Use (Describe)

The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Medartis AG APTUS® Foot System K142581

April 7, 2015

ADMINISTRATIVE INFORMATION

Manufacturer Name	Medartis AG
	Hochbergerstrasse 60E
		CH-4057 Basel, Switzerland
		Telephone:
	Fax:	+41 61 633 34 00
Official Contact	Andrea Schweizer
	Head of Quality Management
Representative/Consultant	Kevin A. Thomas, PhD
	Floyd G. Larson
		PaxMed International, LLC
		12264 El Camino Real, Suite 400
	San Diego, CA 92130
		Telephone:
	Fax:	+1 (858) 792-1236
	Email:	kthomas@paxmed.com
		flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	APTUS® Foot System
Common Name	Plate, fixation, boneScrew, fixation, bone
Classification Names	Single/multiple component metallic bone fixation appliances andaccessoriesSmooth or threaded metallic bone fixation fastener
Classification Regulations	21 CFR 888.3030, 21 CFR 888.3040, Class II
Product Codes	HRS, HWC
Classification PanelReviewing Branch	Orthopedic Products PanelJoint Fixation Devices Branch Two (JFDB2)

INTENDED USE

The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

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DEVICE DESCRIPTION

PERFORMANCE DATA

Performance data provided to demonstrate substantial equivalence included dimensional analysis, engineering analysis, finite element analysis, and mechanical testing. Subject device screws were tested as described in ASTM F543 Standard Specification and Test method for Metallic Bone Screws. including insertion torque, maximum torque, and pull-out testing (subject and predicate screws). Dynamic mechanical testing of the subject and predicate plate designs also was performed.

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent in indications and design principles to the following predicate devices:

K091479, APTUS® Foot System, Medartis AG;

K071264, Synthes (USA) 2.4/2.7 mm Locking Foot Module, Synthes (USA);

K100776, Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot / Midfoot System, Synthes (USA);

K090949, Synthes (USA) 1.5mm Headless Compression Screws, Synthes (USA); and

K101700, IO Fix Hand, IO Fix Foot, Extremity Medical Screw System, Extremity Medical LLC.

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate devices are all fabricated from the same or similar materials and share similar design characteristics, including plate screw holes to accommodate locking and non-locking screws. The subject MTP plates and the predicate K100776 MTP plates encompass the same range of precontoured dorsiflexion. The subject and predicate devices encompass the same range of physical dimensions, and the subject device is compatible with screws from the

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predicate device K091479. The subject and predicate devices are packaged using the same materials, and are to be sterilized by the same methods. Any differences in the technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness.

CONCLUSION

The data included in this submission demonstrate substantial equivalence to the predicate devices listed.

Overall, the subject device has the following similarities to the predicate devices:

has the same intended use,
uses the same operating principle,
incorporates the same basic design,
incorporates the same or very similar materials, and ●
. has similar packaging and is sterilized using the same materials and processes.

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.