(206 days)
No
The summary describes a system of plates and screws for bone fixation, focusing on material properties, dimensions, and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for use in treating fractures, osteotomies, and arthrodesis in small bones, which indicates a therapeutic purpose.
No
The device is described as an implantable system (plates and screws) used for the treatment of fractures, osteotomies, and arthrodeses, rather than for diagnosing conditions.
No
The device description clearly details physical components made of titanium and titanium alloy (plates and screws) intended for surgical implantation. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in small bones for fractures, osteotomies, and arthrodesis. This describes a surgical implant used directly on the patient's body.
- Device Description: The description details plates and screws made of titanium, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
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 subject device plates are provided in a variety of anatomical designs, in various lengths, widths and thicknesses. The plate thickness varies from 1.6 mm to 2.0 mm depending on the design. The screw holes of the subject device plates are designed to accommodate appropriately sized subject device screws, or screws presently marketed as part of the APTUS System and previously cleared under K091479. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are used with TriLock locking screws and cortical (nonlocking) screws. All subject device screws are self-tapping and self-drilling and provided in diameters of 2.0, 2.8 and 3.5 mm, and in various lengths from 8 to 45 mm.
The subject device plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The subject device screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
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)
Performance data provided to demonstrate substantial equivalence included dimensional analysis, engineering analysis, finite element analysis, and mechanical testing. Subject device screws were tested as described in ASTM F543 Standard Specification and Test method for Metallic Bone Screws. including insertion torque, maximum torque, and pull-out testing (subject and predicate screws). Dynamic mechanical testing of the subject and predicate plate designs also was performed.
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K091479, K071264, K100776, K090949, K101700
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medartis AG % Mr. Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
April 9, 2015
Re: K142581 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: Class II Product Code: HRS, HWC Dated: March, 4 2015 Received: March 6, 2015
Dear Mr. 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
1
Page 2 - Mr. Kevin A. Thomas
(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.
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/Resourcesfor You/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/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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142581
Device Name
APTUS® Foot System
Indications for Use (Describe)
The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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510(k) Summary Medartis AG APTUS® Foot System K142581
April 7, 2015
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Medartis AG | ||
|---|---|---|---|
| Hochbergerstrasse 60E | |||
| CH-4057 Basel, Switzerland | |||
| Telephone: | |||
| Fax: | +41 61 633 34 00 | ||
| Official Contact | Andrea Schweizer | ||
| Head of Quality Management | |||
| Representative/Consultant | Kevin A. Thomas, PhD | ||
| Floyd G. Larson | |||
| PaxMed International, LLC | |||
| 12264 El Camino Real, Suite 400 | |||
| San Diego, CA 92130 | |||
| Telephone: | |||
| Fax: | +1 (858) 792-1236 | ||
| Email: | kthomas@paxmed.com | ||
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | APTUS® Foot System |
|---|---|
| Common Name | Plate, fixation, bone |
| Screw, fixation, bone | |
| Classification Names | Single/multiple component metallic bone fixation appliances and |
| accessories | |
| Smooth or threaded metallic bone fixation fastener | |
| Classification Regulations | 21 CFR 888.3030, 21 CFR 888.3040, Class II |
| Product Codes | HRS, HWC |
| Classification Panel | |
| Reviewing Branch | Orthopedic Products Panel |
| Joint Fixation Devices Branch Two (JFDB2) |
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.
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DEVICE DESCRIPTION
The subject device plates are provided in a variety of anatomical designs, in various lengths, widths and thicknesses. The plate thickness varies from 1.6 mm to 2.0 mm depending on the design. The screw holes of the subject device plates are designed to accommodate appropriately sized subject device screws, or screws presently marketed as part of the APTUS System and previously cleared under K091479. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are used with TriLock locking screws and cortical (nonlocking) screws. All subject device screws are self-tapping and self-drilling and provided in diameters of 2.0, 2.8 and 3.5 mm, and in various lengths from 8 to 45 mm.
The subject device plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The subject device screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
PERFORMANCE DATA
Performance data provided to demonstrate substantial equivalence included dimensional analysis, engineering analysis, finite element analysis, and mechanical testing. Subject device screws were tested as described in ASTM F543 Standard Specification and Test method for Metallic Bone Screws. including insertion torque, maximum torque, and pull-out testing (subject and predicate screws). Dynamic mechanical testing of the subject and predicate plate designs also was performed.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the following predicate devices:
K091479, APTUS® Foot System, Medartis AG;
K071264, Synthes (USA) 2.4/2.7 mm Locking Foot Module, Synthes (USA);
K100776, Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot / Midfoot System, Synthes (USA);
K090949, Synthes (USA) 1.5mm Headless Compression Screws, Synthes (USA); and
K101700, IO Fix Hand, IO Fix Foot, Extremity Medical Screw System, Extremity Medical LLC.
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. The subject MTP plates and the predicate K100776 MTP plates encompass the same range of precontoured dorsiflexion. The subject and predicate devices encompass the same range of physical dimensions, and the subject device is compatible with screws from the
5
predicate device K091479. 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 between the subject and predicate devices do not raise different questions of safety or effectiveness.
CONCLUSION
The data included in this submission demonstrate substantial equivalence to the predicate devices listed.
Overall, the subject device 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.