The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand.

Device Description

The APTUS® 2.0/2.3 Four Corner Fusion Plate consists of a titanium fixation plate designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.

AI/ML Overview

The provided text is a 510(k) summary for the Medartis AG APTUS® 2.0/2.3 Four Corner Fusion Plate. This document describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, specific studies (like clinical trials or performance studies), sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot populate the requested table and answer the questions based on the provided text. The document is a regulatory submission for premarket notification, which focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed performance study results against specific criteria.

Summary

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510(k) Summary

APTUS® 2.0/2.3 Four Corner Fusion Plate

K090983

510(k) Summary

Medartis AG APTUS® 2.0/2.3 Four Corner Fusion Plate

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Medartis AG Austrasse 24 CH-4051 Basel, Switzerland Telephone: +41 (0) 61 228 18 18 Fax: +41 (0) 61 228 18 00

Official Contact:

Representative/Consultant:

Rosina Cifelli Regulatory Affairs Manager, Medartis AG

Kevin A. Thomas, PhD Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 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: Common Name: Classification Regulations:

APTUS® 2.0/2.3 Four Corner Fusion Plate 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

Reviewing Branch: INTENDED USE

Classification Panel:

Product Code:

Page 1 of 2

JUL - 1 2009

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510(k) Summary

K090983

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the APTUS® 2.0/2.3 Four Corner Fusion Plate is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices. Overall, the APTUS® 2.0/2.3 Four Corner Fusion Plate 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 materials, and
. has similar packaging and is sterilized using the same materials and processes.

Page 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features an eagle-like emblem with three stylized lines forming its body and wings. The emblem is surrounded by text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Medartis AG % Kevin A. Thomas, Ph.D. Senior Regulatory Specialist PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego. CA 92130

JUL - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Re: K090983

Trade/Device Name: APTUS® 2.0/2.3 Four Corner Fusion Plate Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: II

Product Code: HRS Dated: June 22, 2009 Received: June 23, 2009

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 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,

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Page 2- Kevin A. Thomas, Ph.D

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buehrig

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 (if known): K090983

APTUS® 2.0/2.3 Four Corner Fusion Plate Device Name: .

Indications for Use:

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)


	(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number	K090983
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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.