(55 days)
Not Found
Not Found
No
The summary describes a system of physical implants (plates and screws) for bone fixation and makes no mention of software, algorithms, or any AI/ML related terms.
No
The device is described as a fixation system for internal fixation of small bones in the foot, which is a structural or mechanical function, not a therapeutic one that treats or cures a disease or condition.
No
The device description indicates that the APTUS® Foot System is used for internal fixation of small bones, not for diagnosing conditions.
No
The device description explicitly states it consists of physical components: titanium fixation plates, conventional screws, and locking screws.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The APTUS® Foot System is described as a system of titanium fixation plates and screws intended for internal fixation of bones in the foot. This is a surgical implant used within the body, not a device used to test samples outside the body.
- Intended Use: The intended use is for fixing fractures, osteotomies, and arthrodesis of foot bones. This is a structural and mechanical function, not a diagnostic one based on analyzing biological samples.
Therefore, based on the provided information, the APTUS® Foot System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The APTUS® Foot System consists of small titanium fixation plates, conventional screws and locking screws. The system is intended to be used for internal fixation of small bones in the foot.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
510(k) Summary
JUL 1 3 2009
Medartis AG APTUS® Foot System
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:
Rosina Cifelli Regulatory Affairs Manager, Medartis AG
Representative/Consultant:
Linda K. Schulz 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: lschulz@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name : Classification Regulations:
Product Code: Classification Panel: Reviewing Branch:
APTUS® Foot System Plate, fixation, bone Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030/21 CFR 888.3040 Class II HRS/HWC Orthopedic Products Panel Orthopedic Devices Branch
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.
1
510(k) Summary
K091479 2/2
APTUS® Foot System
DEVICE DESCRIPTION
The APTUS® Foot System consists of small titanium fixation plates, conventional screws and locking screws. The system is intended to be used for internal fixation of small bones in the foot.
EQUIVALENCE TO MARKETED DEVICE
Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the APTUS® Foot System is substantially equivalent to previously cleared devices. The APTUS® Foot System 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. .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1-3 2009
Medartis AG % Ms. Linda K. Schulz PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130
Re: K091479
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: II Product Code: HRS, HWC Dated: May 18, 2009 Received: May 19, 2009
Dear Ms. Schulz:
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 (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 - Ms. Linda K. Schulz
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/cdrb/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 yours.
Obalar Buenno
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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APTUS® Foot System
Indications for Use
510(k) Number (if known): K091479
APTUS® Foot System Device Name:
Indications for 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.
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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Division of Surgical, Orthopedic, and Resiorative Devices
510(k) Number K091479