APTUS® Cannulated Compression Screws 5.0, 7.0 are intended for the treatment of fractures, osteotomies and arthrodeses of bones with the appropriate screw size.

Device Description

APTUS® Cannulated Compression Screws 5.0, 7.0 are headless screws intended for the treatment of fractures, osteotomies and arthrodeses of bones. The design of the screw, incorporating various diameters, threads on the head and tip, provides compression of the bone segments upon insertion of the screw. The submission includes the associated Kwires, intended to be used for internal fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of the implants.

APTUS Cannulated Compression Screws 5.0, 7.0 are available in two diameters (5.0 mm and 7.0 mm) and come in partially-threaded or fully-threaded designs. The 5.0 mm screws are provided in overall lengths ranging from 30 to 70 mm. The 7.0 mm screws are provided in overall lengths ranging from 40 to 140 mm. The 5.0 and 7.0 mm screws are used with the 1.6 and 2.2 mm diameter K-wires, respectively.

APTUS® Cannulated Compression Screws 5.0, 7.0 are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and the K-wires are made of stainless steel conforming to ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study proving device performance:

This 510(k) summary is for a medical device (APTUS® Cannulated Compression Screws 5.0, 7.0), not an AI/software device. Therefore, many of the typical acceptance criteria and study aspects related to AI (e.g., sample size for test set, data provenance, ground truth experts, MRMC studies, standalone performance, training set) are not applicable.

The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical data, primarily engineering and mechanical testing. Clinical data was explicitly not submitted.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Since this is a hardware device submission, the "acceptance criteria" are related to mechanical performance and regulatory standards, not diagnostic accuracy or AI model performance.

Acceptance Criteria (Standard/Test)	Reported Device Performance
ASTM F543 Standard Specification and Test Method for Metallic Bone Screws	Side-by-side testing of screws performed, demonstrating substantial equivalence to predicate devices.
Engineering Analysis	Performed to establish substantial equivalence.
Dimensional Analysis	Performed to establish substantial equivalence.

2. Sample size used for the test set and the data provenance

Test set sample size: Not applicable in the context of AI/software performance. For mechanical testing, the specific number of screws tested is not detailed in this summary, but it would typically involve a statistically relevant number of samples to demonstrate compliance with ASTM F543.
Data provenance: Not applicable in the context of data used for AI training/testing. The tests were performed on the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically defined for AI (e.g., expert consensus on medical images) is not relevant for mechanical testing of bone screws. The "ground truth" here is compliance with established engineering and material standards.

4. Adjudication method for the test set

Not applicable. No expert adjudication process as understood in AI performance evaluations. Mechanical tests have pass/fail criteria based on standards.

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

No. This is a hardware device, not an AI-assisted diagnostic tool.

6. 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.

7. The type of ground truth used

Engineering and material standards compliance: The "ground truth" for this device revolves around its conformance to established material specifications (e.g., ASTM F136 for titanium alloy, ASTM F138 for stainless steel) and mechanical performance standards (ASTM F543 for metallic bone screws). The tests demonstrated that the device performs equivalently to previously cleared predicate devices when subjected to these standards.

8. The sample size for the training set

Not applicable. This is a hardware device; there is no "training set" in the AI sense.

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

Not applicable. This is a hardware device.

Summary

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510(k) Summary

K133460 page 1 of 3

DEC 18 2013

・・・

Medartis AG

APTUS® Cannulated Compression Screws 5.0, 7.0

November 11, 2013

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

Representative/Consultant

Andrea Schweizer Group Manager Compliance & Vigilance

Allison C. Komiyama, Ph.D. 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: akomiyama@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name Common Name

Classification Name Classification Regulations Product Code

Classification Panel Reviewing Branch

APTUS® Cannulated Compression Screws Screw, fixation, bone

Smooth or threaded metallic bone fixation fastener 21 CFR 888.3040. Class II HWC. HTY

Orthopedic Products Panel Orthopedic Devices Branch

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K133460 page 2 of 3

INTENDED USE

APTUS® Cannulated Compression Screws 5.0, 7.0 are intended for the treatment of fractures, osteotomies and arthrodeses of bones with the appropriate screw size.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

APTUS® Cannulated Compression Screws 5.0, 7.0 are substantially equivalent in indications and design principles to the following predicate devices:

Medartis AG, APTUS® K-Wire System (K092038) .
Medartis AG, APTUS® Cannulated Compression Screws (K110658) .
Synthes (USA), Synthes 4.5 mm and 6.5 mm Headless Compression Screws (K080943) .
. Synthes (USA), Synthes 7.0/7.3 mm Cannulated Screws (K962011)
Wright Medical Technology, Inc., DARCO® Headless Compression Screw (K080850) .

APTUS® Cannulated Compression Screws 5.0. 7.0 have similar designs and identical materials as those cleared under K092038 and K110658. The subject device is similar in indications to those cleared in K110658, K080943, K962011, and K080850. The designs and dimensions of the subject device are similar and within the range of those cleared in K080943. K962011, and K080850.

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510(k) Summary

K133460 page 3 of 3

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: engineering analysis, dimensional analysis and mechanical testing. APTUS® Cannulated Compression Screws 5.0, 7.0 were subjected to mechanical performance testing following the FDA recognized standard ASTM F543 Standard Specification and Test Method for Metallic Bone Screws. Side-by-side testing of screws was performed utilizing the subject and predicate devices cleared in K080943, K962011, and K080850.

Clinical data were not submitted in this premarket notification.

Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

Overall. APTUS® Cannulated Compression Screws 5.0, 7.0 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

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

December 18, 2013

Medartis AG % Allison C. Komiyama, Ph.D. PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K133460

Trade/Device Name: APTUS® Cannulated Compression Screws 5.0, 7.0 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTY Dated: November 11, 2013 Received: November 12, 2013

Dear Dr. Komiyama:

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. Iisting 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 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.

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Page 2 - Allison C. Komiyama. Ph.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (21 CFR 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 CDRH1'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 vours.

Ronalding Nean -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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5.10(k) Summary

APTUS® Cannulated Compression Screws 5.0, 7.0

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Indications for Use

K133460 510(k) Number:

APTUS® Cannulated Compression Screws 5.0, 7.0 Device Name:

Indications for Use:

APTUS® Cannulated Compression Screws 5.0, 7.0 are intended for the treatment of fractures. osteotomies and arthrodeses of bones with the appropriate screw size.

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 I of I

Elizabeth & Frank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.