(280 days)
Not Found
No
The device description focuses on the materials and types of plates, screws, and instruments. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The performance studies described are mechanical fatigue tests, not studies related to algorithmic performance.
Yes.
The device is indicated for use in fractures, osteotomies, and arthrodesis, which are treatments for medical conditions.
No
The device is a surgical implant and associated instruments used for fixing fractures, performing osteotomies, and arthrodesis in the foot. It is used in reconstructive surgery rather than for diagnosing a condition.
No
The device description explicitly details various hardware components made of titanium and stainless steel, including screws, plates, K-wires, and wedges, which are physical implants and instruments. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges." This describes a surgical procedure to treat bone conditions.
- Device Description: The device consists of "sterile screws," "plates," "K-Wires," and "wedges." These are all physical implants and surgical tools used directly on the patient's body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the APTUS Foot System does not involve any such testing of biological samples.
Therefore, the APTUS Foot System is a surgical implant and instrument system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The APTUS Foot System 2.8-3.5 is indicated for use in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, PLF
Device Description
The subject device sterile screws consist of sterile TriLock screws (locking), Cortical and Cancellous screws (non-locking).
The APTUS TriLock Screws, Cortical Screws and Cancellous Screws that are compatible with the subject device plate are manufactured from titanium alloy conforming to ASTM F136.
The APTUS K-Wires that are compatible with the subject device plates are manufactured from stainless steel conforming to ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).
The device-specific instruments (templates) are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700).
The subject device Medartis APTUS Foot System 2.8-3.5 consisting of following plates and systems: 2.8 TriLock Plate Straight, 2.8 TriLock Plate Hole T Extended and 2.8 TriLock TMT-1 Medial Fusion Plates Large, APTUS Mid- and Hindfoot System 2.8/3.5 and Fusion System 3.5.
The APTUS Mid- and Hindfoot System 2.8/3.5 includes TriLock 2.8 C Plates, 2.8 TriLock Calcaneus LCL Plates, 3.5 TriLock Calcaneus LCL Plates and 3.5 TriLock Calcaneus Step Plates. The subject device also includes sterile wedges that are used to support fixation of an opening wedge osteotomy. The wedges are stabilized by corresponding wedge screws that are placed through a plate. The subject device wedges are provided in two size series.
The APTUS Fusion System 3.5 includes 3.5 TriLock Wing Plates, 3.5 TriLock Butterfly Plates, 3.5 TriLock TNC Fusion Plates, 3.5 TriLock NCM Fusion Plates, 3.5 TriLock TNCM Fusion Plates, 3.5 TriLock Talonavicular Fusion Plates. Furthermore, 3.5 TriLock Medial Column Fusion Plates, 3.5 TriLock Distal Medial Column Fusion Plates, 3.5 TriLock Proximal Column Fusion Plates.
The APTUS Fusion System 3.5 plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The 2.8 TriLock Straight Plates are generic straight plates and used with 2.8 mm screws. The 2.8 TriLock Plate Hole T Extended are generic T plates and used with 2.8 mm screws. The 2.8 TriLock TMT-1 Medial Fusion Plates Large plates have anatomical designs that are appropriate for either the left or the right foot.
The subject device plates are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700).
The subject device sterile screws consist of sterile TriLock screws (locking), Cortical and Cancellous screws (non-locking).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Fatigue testing was performed with the Plates of Mid-and Hindfoot System 2.8/3.5 and Fusion Plates according to ASTM F382-17 to demonstrate equivalence to the predicate devices listed in K193639, K091479, K052614 and K150520. Foot Plates are covered by the worst case product cleared in K091479. Worst case plates were identified based on their out of plane bending moments of inertia.
The mechanical test results show that the acceptance criteria were met. Clinical data were not provided 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.
K193639, K223853, K091479, K052614, K150520, K103332, K193633, K110908
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
April 19, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Medartis AG Claudia Santis Head of Regulatory Affairs Hochbergerstrasse 60E Basel, Basel-Stadt CH-4057 Switzerland
Re: K232105
Trade/Device Name: APTUS Foot System 2.8-3.5 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, PLF Dated: March 13, 2024 Received: March 21, 2024
Dear Claudia Santis:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tejen D. Soni -S
For
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
APTUS Foot System 2.8-3.5
Indications for Use (Describe)
The APTUS Foot System 2.8-3.5 is indicated for use 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
Prepared on: 2024-04-10
Contact Details
| Applicant Name | Medartis AG | |
|---|---|---|
| Applicant Address | Hochbergerstrasse 60E Basel BS 4057 Switzerland | |
| Applicant Contact Telephone | +41 798835288 | |
| Applicant Contact | Mrs. Claudia De Santis | |
| Applicant Contact Email | claudia.desantis@medartis.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | APTUS Foot System 2.8-3.5 | |
| Common Name | Plate, Fixation, Bone (Primary); | |
| Screw, Fixation, Bone; | ||
| Bone Wedge | ||
| Classification Name | Single/multiple component metallic bone fixation appliances and | |
| accessories (Primary); | ||
| Smooth or threaded metallic bone fixation fastener | ||
| Regulation Number | 21 CFR 888.3030 (Primary); 21 CFR 888.3040 | |
| Product Code(s) | HRS (Primary); HWC; PLF | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K193639 | APTUS® Foot 2.8 – 3.5 System | HRS |
| K223853 | Medartis APTUS® Ulna Plates | HRS |
| K091479 | APTUS FOOT SYSTEM | HRS |
| K052614 | LOW PROFILE PLATE AND SCREW SYSTEM | HRS |
| K150520 | DARCO Locking Bone Plate System | HRS |
| K103332 | APTUS ULNA PLATES | HRS |
| K193633 | APTUS® Ankle Trauma System 2.8/3.5 | HRS |
| K110908 | APTUS FOOT 3.5 SYSTEM | HRS |
| Device Description Summary | 21 CFR 807.92(a)(4) | |
| The subject device sterile screws consist of sterile TriLock screws (locking), Cortical and Cancellous screws (non-locking). | ||
| The APTUS TriLock Screws, Cortical Screws and Cancellous Screws that are compatible with the subject device plate are manufactured from titanium alloy conforming to ASTM F136. | ||
| The APTUS K-Wires that are compatible with the subject device plates are manufactured from stainless steel conforming to ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673). | ||
| The device-specific instruments (templates) are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700). | ||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | |
| The APTUS Foot System 2.8-3.5 is indicated for use in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges. | ||
| Indications for Use Comparison | 21 CFR 807.92(a)(5) | |
| The Indications for Use Statements (IFUS) for the subject device and the primary predicate device K193639 include language for fractures, osteotomies and arthrodesis, in particular for the tarsals, metatarsals and phalanges. The IFUS for the subject device and the primary predicate device K193639 is identical. | ||
| Technological Comparison | 21 CFR 807.92(a)(6) | |
| The primary predicate device K193639 is in support of substantial equivalence for the subject device in terms of identical IFUs, similar plate designs; compatible screw and K-wire designs (use with locking and non-locking screws); identical plate materials and the same non-sterile packaging. The primary predicate device K193639 is also for support of substantial equivalence in terms of comparative mechanical testing. | ||
| The additional predicate device K223853 is in support of substantial equivalence for the subject device in terms of identical plate material, similar technological and design characteristics, including use with locking and non-locking screws and K-wires, same sterilization for devices provided nonsterile, same sterilization for devices provided sterile, the same packaging, and the same sterile barrier shelf life. | ||
| The additional predicate K223853 is also for support of substantial equivalence in terms of | ||
| K232105 - Page 2 of 3 |
The purpose of this submission is to obtain marketing clearance for an additional device design to expand the range of the Medartis APTUS Foot System 2.8-3.5 previously cleared under K193639.
4
The subject device Medartis APTUS Foot System 2.8-3.5 consisting of following plates and systems: 2.8 TriLock Plate Straight, 2.8 TriLock Plate Hole T Extended and 2.8 TriLock TMT-1 Medial Fusion Plates Large, APTUS Mid- and Hindfoot System 2.8/3.5 and Fusion System 3.5.
The APTUS Mid- and Hindfoot System 2.8/3.5 includes TriLock 2.8 C Plates, 2.8 TriLock Calcaneus LCL Plates, 3.5 TriLock Calcaneus LCL Plates and 3.5 TriLock Calcaneus Step Plates. The subject device also includes sterile wedges that are used to support fixation of an opening wedge osteotomy. The wedges are stabilized by corresponding wedge screws that are placed through a plate. The subject device wedges are provided in two size series.
The APTUS Fusion System 3.5 includes 3.5 TriLock Wing Plates, 3.5 TriLock Butterfly Plates, 3.5 TriLock TNC Fusion Plates, 3.5 TriLock NCM Fusion Plates, 3.5 TriLock TNCM Fusion Plates, 3.5 TriLock Talonavicular Fusion Plates. Furthermore, 3.5 TriLock Medial Column Fusion Plates, 3.5 TriLock Distal Medial Column Fusion Plates, 3.5 TriLock Proximal Column Fusion Plates.
The APTUS Fusion System 3.5 plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The 2.8 TriLock Straight Plates are generic straight plates and used with 2.8 mm screws. The 2.8 TriLock Plate Hole T Extended are generic T plates and used with 2.8 mm screws. The 2.8 TriLock TMT-1 Medial Fusion Plates Large plates have anatomical designs that are appropriate for either the left or the right foot.
The subject device plates are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700).
The subject device sterile screws consist of sterile TriLock screws (locking), Cortical and Cancellous
screws (non-locking).
ges.
IFUS
5
comparative sterilization and shelf life.
The primary predicate device K193639 and the additional predicate devices K091479, K052614 and K150520 are in support of substantial equivalence for the subject device in terms similar plate designs, compatible screw and K-wire designs (use with locking and non-locking screws); identical plate materials and the same non-sterile packaging. The additional predicates are also for support of substantial equivalence in terms of comparative mechanical testing.
The screws from the subject device have the same technological characteristics, identical design characteristics, and identical material previously cleared in K193639, K091479, K103332 and K110908.
The additional predicate device K193633 is in support of substantial equivalence for the subject device in terms of identical screw material, similar technological and design characteristics, same sterilization for devices provided nonsterile, same sterilization for devices provided sterile, the same packaging, and the same sterile barrier shelf life. The additional predicate device K193633 is also for support of substantial equivalence in terms of comparative sterilization and shelf life.
The basis for the belief of Medartis AG that the subject device is substantially equivalent to the predicate devices is summarized in the Tables of Substantial Equivalence.
The primary predicate device K193639 is in support of substantial equivalence for the device specific (Class II) instruments and accessories in terms of same materials, same packaging, and same sterilization (moist heat by end user).
The subject device and the device specific (Class II) instruments and accessories are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the primary predicate device K193639 and the additional predicate devices K223853, K091479, K103332 K110908 and therefore, are substantially equivalent to these previously-cleared devices regarding biocompatibility.
CONCLUSION
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 materials, and
· has the same packaging and is sterilized using the same materials and processes.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Fatigue testing was performed with the Plates of Mid-and Hindfoot System 2.8/3.5 and Fusion Plates according to ASTM F382-17 to demonstrate equivalence to the predicate devices listed in K193639, K091479, K052614 and K150520. Foot Plates are covered by the worst case product cleared in K091479. Worst case plates were identified based on their out of plane bending moments of inertia.
Not Applicable
The mechanical test results show that the acceptance criteria were met. Clinical data were not provided in this submission.