(89 days)
The APTUS® Foot 3.5 System is indicated for fractures and osteotomies of the calcaneus.
The APTUS® Foot 3.5 System consists of titanium locking plates and titanium locking and non-locking screws. Plates are provided in three sizes in designs specifically for the right and left calcaneus. The plates are used with TriLock (locking) screws or cortical (non-locking) screws having self-tapping cortical thread forms and a thread diameter of 3.5 mm. The screws are provided in various overall lengths ranging from 16 mm to 60 mm. APTUS Foot 3.5 System plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67. APTUS TriLock and cortical screws are made of titanium alloy conforming to ASTM F136.
1. Acceptance Criteria and Reported Device Performance:
The provided document does not contain specific acceptance criteria or quantitative performance data for the APTUS® Foot 3.5 System. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The performance data mentioned is to establish this equivalence, not to meet specific, quantifiable acceptance criteria in the way one might see for a diagnostic AI device.
Table of Acceptance Criteria and Reported Device Performance (Based on the provided text):
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence to Predicate Devices | - Same intended use | - "has the same intended use." |
| - Same operating principles | - "uses the same operating principles." | |
| - Same basic designs | - "incorporates the same basic designs." | |
| - Same or very similar materials | - "incorporates the same or very similar materials." (Titanium locking plates, titanium locking/non-locking screws; Commercially pure titanium, Grade 4 for plates; Titanium alloy conforming to ASTM F136 for screws) | |
| - Similar packaging and sterilization methods | - "has similar packaging and is sterilized using the same materials and processes." | |
| - No new issues of safety or efficacy due to technological differences | - "Any differences in the technological characteristics do not raise new issues of safety or efficacy." | |
| Material Conformance | - Plates conform to ASTM F67 | - "APTUS Foot 3.5 System plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67." |
| - Screws conform to ASTM F136 | - "APTUS TriLock and cortical screws are made of titanium alloy conforming to ASTM F136." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a test set in the context of evaluating an AI or diagnostic device. The "performance data" mentioned refers to engineering tests and dimensional analyses used to demonstrate physical and functional equivalence to predicate devices, not clinical data from a "test set" of patients or images.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This information is not relevant to a medical device submission focused on substantial equivalence through material and design comparison, rather than diagnostic performance assessed against a ground truth.
4. Adjudication Method for the Test Set:
Not applicable. There is no described "test set" or diagnostic evaluation that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. The product is a bone fixation system (plates and screws), not an AI algorithm or a diagnostic tool that would be evaluated in an MRMC study.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
Not applicable in the context of a diagnostic or AI device. The "ground truth" for this device's performance would be its mechanical properties, biocompatibility, and ability to fulfill its intended function (fracture fixation), which are assessed through engineering tests and material standards, not against clinical ground truth data like pathology or outcomes for diagnostic accuracy.
8. Sample Size for the Training Set:
Not applicable. The APTUS® Foot 3.5 System is a manufactured medical implant, not an AI or machine learning model that requires a training set.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this device.
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APTUS
Foot 3.5 System
K110908 1/2
510(k) Summary
JUN 2 8 2011
Medartis AG
APTUS® Foot 3.5 System
March 30, 2011
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Medartis AGHochbergerstrasse 60ECH-4057 Basel, SwitzerlandTelephone: +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 92130Telephone: +1 (858) 792-1235Fax: +1 (858) 792-1236Email: kthomas@paxmed.comflarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
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| Trade/Proprietary Name: | APTUS® Foot 3.5 System |
|---|---|
| Common Name: | Plate, fixation, bone |
| Classification Regulations: | Single/multiple component metallic bone fixationappliances and accessories21 CFR 888.3030, Class II |
| Product Codes: | HRS |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
INTENDED USE
...
The APTUS® Foot 3.5 System is indicated for fractures and osteotomies of the calcaneus.
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APTUS® Foot 3.5 System
K110908 2/2
DEVICE DESCRIPTION
The APTUS® Foot 3.5 System consists of titanium locking plates and titanium locking and non-locking screws. Plates are provided in three sizes in designs specifically for the right and left calcaneus. The plates are used with TriLock (locking) screws or cortical (non-locking) screws having self-tapping cortical thread forms and a thread diameter of 3.5 mm. The screws are provided in various overall lengths ranging from 16 mm to 60 mm. APTUS Foot 3.5 System plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67. APTUS TriLock and cortical screws are made of titanium alloy conforming to ASTM F136.
EQUIVALENCE TO MARKETED DEVICE
APTUS® Foot 3.5 System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:
Synthes (USA), Synthes Locking Calcaneal Plates, cleared under K991407, and Medartis AG, APTUS® Foot System, cleared under K091479.
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 similar 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 was provided to demonstrate substantial equivalence and included detailed dimensional analysis of the subject and predicate designs, and testing of the subject and predicate plates and screws.
Overall, APTUS Foot 3.5 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 and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is written around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Medartis AG % PaxMed International, LLC % Kevin A. Thomas, Ph.D. 11234 El Camino Real, Suite 200 San Diego, CA 92130
JUN 2 8 2011
Re: K110908
Trade/Device Name: APTUS Foot 3.5 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: June 7, 2011 Received: June 8, 2011
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
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Page 2 - Kevin A. Thomas, Ph.D.
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. 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.
http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.
Sincerely yours,
E. Keith
Mar
Dire
Divi
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:
APTUS® Foot 3.5 System Device Name:
Indications for Use:
The APTUS® Foot 3.5 System is indicated for fractures and osteotomies of the calcaneus.
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 ・・ rom (Division Sign-Oft) (Division Bignical, Orthopedic, Divisionative Devices 510(k) Number
§ 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.