APTUS Ulna Shortening 2.5 system consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K051567), both locking and nonlocking. This submission includes additional lengths of non-locking screws. Plates have a low overall height, rounded edges, polished surfaces and incorporate TriLock Technology with use of TriLock (locking) screws. All plates are made from unalloyed titanium conforming to ASTM F67, and all screws are made from titanium alloy conforming to ASTM F136.

AI/ML Overview

This is a medical device 510(k) summary, not a study describing AI/algorithm performance. Therefore, most of the requested information about acceptance criteria, study design, and AI model specifics is not applicable.

The document describes the APTUS® Ulna Shortening 2.5 system, which consists of titanium locking plates and screws used for ulna fractures and osteotomies. The approval is based on demonstrating substantial equivalence to existing, legally marketed predicate devices, not on proving performance against specific acceptance criteria in a clinical or AI-based study.

Here's a breakdown of what can be extracted and why other parts are not applicable:

A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense. This is not an AI/algorithm study with performance metrics like sensitivity, specificity, etc.
- The "acceptance criteria" here relate to demonstrating substantial equivalence (SE) to predicate devices. The "reported device performance" refers to the data provided to support this equivalence.
- Acceptance Criteria for Substantial Equivalence (implied):
  - Same intended use.
  - Same technological characteristics (or differences don't raise new safety/efficacy issues).
  - Same or similar materials.
  - Similar design characteristics.
  - Same range of physical dimensions.
  - Compatible with screws from predicate devices.
  - Same packaging and sterilization methods.
  - Performance data (dimensional analysis, engineering analysis, dynamic mechanical testing) to support equivalence.
- Reported Device Performance: "Performance data provided to demonstrate substantial equivalence included detailed dimensional analysis of the subject and predicate device designs, engineering analysis and dynamic mechanical testing of the subject and predicate plate designs." No specific metrics (e.g., strength in Newtons) are provided in this summary.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is not a study that uses a "test set" of patient data in the context of an algorithm or clinical trial. The "testing" refers to mechanical and engineering tests of the device components. Details on the sample sizes for these mechanical tests are not provided in this summary.
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)
- Not Applicable. "Ground truth" in the context of medical device approval for equivalence generally refers to engineering specifications, material properties, and established medical standards. There is no mention of experts establishing a "ground truth" for a test set in the way an AI algorithm would require.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is used as this is not a study involving human reader interpretation of data.
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
- Not Applicable. This is a hardware device (bone plate and screws), not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study with AI assistance was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable in the AI/clinical study sense. The "ground truth" for this device's approval is based on established engineering principles, material science standards (ASTM F67, ASTM F136), and regulatory requirements for demonstrating substantial equivalence to predicate devices that have a history of safe and effective use.
The sample size for the training set
- Not Applicable. This is a hardware device; there is no "training set" in the context of an AI algorithm.
How the ground truth for the training set was established
- Not Applicable. See point 8.

Summary

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APTUS® Ulna Shortening 2.5

510(k) Summary

Medartis AG

APTUS® Ulna Shortening 2.5

May 12, 2014

ADMINISTRATIVE INFORMATION

Manufacturer Name	Medartis AG
	Hochbergerstrasse 60E
	CH-4057 Basel, Switzerland
Telephone:	+41 61 633 34 34
Fax:	+41 61 633 34 00
Official Contact:	Andrea Schweizer
	Group Manager Compliance & Vigilance
Representative/Consultant	Kevin A. Thomas, PhD
	Floyd G. Larson
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
Telephone:	+1 (858) 792-1235
Fax:	+1 (858) 792-1236
Email:	kthomas@paxmed.com
	flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	APTUS® Ulna Shortening 2.5
Common Name:	Plate, fixation, boneScrew, Fixation, Bone
Classification Name:	Single/multiple component metallic bone fixation appliancesand accessoriesSmooth or threaded metallic bone fixation fastener
Classification Regulation:	21 CFR 888.3030, 21 CFR 888.3040, Class II
Product Code:	HRS, HWC
Classification Panel:	Orthopedic Products Panel
Reviewing Branch:	Joint Fixation Devices Branch Two (JFDB2)

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510(k) Summary

APTUS® Ulna Shortening 2.5

INTENDED USE

APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

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

Medartis, Inc., APTUS® Titanium Fixation System, cleared under K051567;

Medartis AG. APTUS® Ulna Plates, cleared under K103332; and

TriMed Inc., TriMed Ulnar Osteotomy Plate, cleared under K043263.

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, and a screw hole angled for placement of a screw perpendicular to a 45° osteotomy. The subject and predicate devices encompass the same range of physical dimensions, and the subject device is compatible with screws from the predicate devices K103332 and K051567. 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 do not raise new issues of safety or efficacy.

Performance data provided to demonstrate substantial equivalence included detailed dimensional analysis of the subject and predicate device designs, engineering analysis and dynamic mechanical testing of the subject and predicate plate designs.

Overall, APTUS® Ulna Shortening 2.5 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.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present.

Public Health Service

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

June 23, 2014

Medartis AG % Mr. Kevin A. Thomas, PhD Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego. California 92130

Re: K141232

Trade/Device Name: APTUS™ Ulna Shortening 2.5 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: May 12, 2014 Received: May 13. 2014

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. 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 - Kevin A. Thomas, PhD

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 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/ResourcesforYou/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/MedicalDcvices/Safety/ReportaProblem/default.hun 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,

Lori A. Wiggins

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K141232 510(k) Number:

APTUS® Ulna Shortening 2.5 Device Name:

APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.

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)

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Elizabet情況

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K141232

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.