APTUS Proximal Humerus System consists of titanium locking plates, locking and non-locking titanium screws, spiral blades left/ right and the corresponding screws for the spiral blades. The plates are used with TriLock locking screws and cortical screws. APTUS Proximal Humerus plates and spiral blades are made of commercially pure titanium, grade 4, conforming to ASTM F67. TriLock locking and cortical screws are made of titanium alloy conforming to ASTM F136.

AI/ML Overview

This document pertains to the clearance of the APTUS® Proximal Humerus System, a medical device, and does not involve AI/ML software. Therefore, many of the requested sections regarding AI/ML performance metrics, ground truth establishment, and training/test sets are not applicable.

Here's an analysis of the provided information:

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

The acceptance criteria for this device are based on demonstrating substantial equivalence to legally marketed predicate devices. This is achieved through engineering and performance testing that shows the device has similar characteristics, intended use, operating principles, materials, and designs, and does not raise new issues of safety or efficacy.

Acceptance Criteria Category	Reported Device Performance (APTUS® Proximal Humerus System)
Intended Use	Same as predicate devices: for fractures, osteotomies, and non-unions of the proximal humerus.
Technological Characteristics	Same as predicate devices, including design principles, materials (commercially pure titanium, grade 4, and titanium alloy conforming to ASTM F136), and functionality. Differences do not raise new safety/efficacy issues.
Materials	Commercially pure titanium, grade 4 (plates, spiral blades); Titanium alloy conforming to ASTM F136 (locking/cortical screws). Matches or is similar to predicate devices.
Design	Basic designs are the same as predicate devices.
Operating Principles	Same as predicate devices.
Physical Dimensions	Encompasses the same range as predicate devices.
Packaging & Sterilization	Same materials and methods as predicate devices.
Performance Data	Detailed dimensional and engineering analysis (including fatigue testing of subject device and predicate device plate and screw constructs) provided to demonstrate substantial equivalence.
Safety & Efficacy	No new issues of safety or efficacy are raised by the device's characteristics compared to predicates.

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

This information is not applicable (N/A) as the clearance is for a physical medical device (bone fixation system), not an AI/ML software. The "testing" refers to mechanical and engineering performance tests on the device and predicate devices, not on a dataset of patient data.

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)

N/A. Ground truth for an AI/ML model is not relevant here. The "ground truth" for this device's performance is established through engineering standards and testing methodologies for mechanical properties and biological compatibility.

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

N/A. This refers to adjudication of expert labels for AI/ML validation, which is not relevant for this device.

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

N/A. This device does not involve AI assistance or human readers.

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

N/A. This is a physical device, not an algorithm.

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

N/A. The "ground truth" for this device's performance is based on established engineering principles, materials science, and bio-compatibility standards (e.g., ASTM standards for materials, fatigue testing protocols). Performance is compared against predicate devices and relevant industry standards.

8. The sample size for the training set

N/A. This is not an AI/ML model.

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

N/A. This is not an AI/ML model.

In summary, the APTUS® Proximal Humerus System achieved clearance by demonstrating substantial equivalence to several predicate devices through detailed dimensional, engineering, and fatigue testing, confirming that its materials, design, intended use, and performance characteristics are comparable and do not introduce new safety or efficacy concerns.

Summary

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·APTUS® Proximal Humerus System

510(k) Summary K120108

APR 2 7 2012

510(k) Summary

Medartis AG

APTUS® Proximal Humerus System K120108

April 26, 2012

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Medartis AGHochbergerstrasse 60ECH-4057 Basel, Switzerland
	Telephone: +41 61 633 34 34Fax: +41 61 633 34 00
Official Contact:	Ulrike JehleRegulatory Affairs Manager, Medartis AG
Representative/Consultant:	Kevin A. Thomas, PhDFloyd G. LarsonPaxMed International, LLC11234 El Camino Real, Suite 200San Diego, CA 92130 USA
	Telephone: +1 (858) 792-1235Fax: +1 (858) 792-1236Email: kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Name:

Classification Regulation: Product Code:

Classification Panel: Reviewing Branch:

APTUS® Proximal Humerus System Plate, fixation, bone Single/multiple component metallic bone fixation appliances and accessories

21 CFR 888.3030, Class II HRS

Orthopedic Products Panel Orthopedic Devices Branch

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510(k) Summary K120108

INTENDED USE

APTUS® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the proximal humerus.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

APTUS® Proximal Humerus System is substantially equivalent in indications and design principles to the following legally marketed predicate devices, each of which has been determined by FDA to be substantially equivalent to a legally marketed predicate device:

Synthes (USA), Synthes LCP Proximal Humerus Plate, cleared under K011815;

Synthes (USA), Synthes (USA) LCP® Proximal Humerus Plates, long, cleared under K041860; and

Exactech, Inc., Exactech® Equinoxe® Proximal Humerus Fracture Plate System, cleared under K093978.

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. The subject and predicate devices encompass the same range of physical dimensions, are packaged using the same materials, and are to be sterilized by the same methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy.

Performance data provided to demonstrate substantial equivalence included detailed dimensional and engineering analysis of the subject and predicate devices, and fatigue testing of subject device and predicate device plate and screw constructs.

Overall, the APTUS Proximal Humerus System has the following similarities to the predicate devices:

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like strokes, symbolizing growth and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

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

Medartis AG % Paxmed International LLC Dr. Kevin A. Thomas Vice President and Director of Regulatory Affairs 11234 El Camino Real, Suite 200 San Diego, California 92130

APR 2 7 2012

Re: K120108 Trade/Device Name: APTUS® Proximal Humerus 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: April 23, 2012 Received: April 24, 2012

Dear Dr. 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.

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

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Page 2 - Kevin A. Thomas, PhD

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 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 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:

K120108

Device Name:

APTUS® Proximal Humerus System

Indications for Use:

APTUS® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the proximal humerus.

Prescription · Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Ast

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

K120108 510(k) Number _

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.