(59 days)
APTUS® Cannulated Compression Screws and headed Cannulated Compression Screws are intended for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size.
APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.
The subject device includes APTUS Cannulated Compression Screws in thread diameters 1.7 mm, 2.2 mm, 3.0 mm, 5.0 mm, and APTUS headed Cannulated Compression Screws in diameters 2.2 mm, 3.0 mm, 5.0 mm, and 7.0 mm. APTUS Cannulated Compression Screws are headless screws that incorporate threads with different pitch on the head and tip of the screws; this difference in pitch provides compression as the screw is inserted. APTUS headed Cannulated Compression Screws have conventional bone screw heads that apply compression between the threads and the head. Both types of screws provide compression of the bone segments upon insertion of the screw. Additionally, all subject device screws have a triangular SpeedTip® shape designed to improve cutting and insertion torque and an internal hexalobular instrument face.
The APTUS Cannulated Compression Screws and APTUS headed Cannulated Compression Screws come in partially threaded and fully threaded designs. The 1.7 mm diameter screws are provided in overall lengths ranging from 8 mm to 20 mm. The 2.2 mm diameter screw are provided in overall lengths ranging from 10 mm to 40 mm. The 3.0 mm diameter screws are provided in overall lengths ranging from 10 mm to 40 mm. The 4.0 mm diameter screws are provided in overall lengths ranging from 16 mm to 60 mm. The 5.0 mm diameter screws are provided in overall lengths ranging from 24 mm to 70 mm. The 7.0 mm diameter screws are provided in overall lengths ranging from 30 mm to 140 mm.
The subject device 1.7 mm, 2.2 mm, 4.0 mm, 5.0 mm, and 7.0 mm thread diameter APTUS Cannulated Compression Screws and APTUS headed Cannulated Compression screws are used with the corresponding subject device K-wires (0.6, 0.8, 1.1, 1.25, 1.6, and 2.2 mm, respectively). The subject device screws also are compatible with the Medartis K-wires cleared under K092038. Similarly, the subject device K-wires are compatible with the APTUS Cannulated Compression Screws cleared under K133460 and K110658.
This submission also includes the corresponding washers for APTUS headed Cannulated Compression Screws.
The subject device cannulated compression screws and washers are manufactured from titanium allov conforming to ASTM F136 Standard Specification for Wrought Titanium-61 anadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The subject device K-wires 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).
All subject devices are provided non-sterile to the end user. The subject devices are single-use only.
This document describes a 510(k) premarket notification for Medartis AG's APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, and APTUS K-Wire System. This is a submission for medical devices that are typically evaluated based on substantial equivalence to predicate devices, rather than strict performance against predefined acceptance criteria for a new clinical indication. Therefore, the information you've requested regarding acceptance criteria and a study proving those criteria are met is not directly applicable in the context of this 510(k) submission as it would be for a novel diagnostic AI device.
Instead, the submission focuses on demonstrating that the new devices are "substantially equivalent" to already legally marketed predicate devices. This is typically done through comparisons of:
- Intended Use/Indications for Use: Ensuring the new device is used for the same purpose and in similar patient populations as the predicate.
- Technological Characteristics: Comparing materials, design, operating principles, and performance.
- Performance Data: This is usually non-clinical testing (e.g., mechanical, biocompatibility, sterilization) to show that any differences in technological characteristics do not raise new questions of safety or effectiveness. Clinical data are often not required for 510(k) submissions unless deemed necessary to address a specific safety or effectiveness concern.
Given this context, I will address your points based on the information provided in the document, interpreting "acceptance criteria" through the lens of "substantial equivalence" as demonstrated by the non-clinical performance data.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for substantial equivalence rather than a device with a novel performance claim requiring specific clinical acceptance criteria, the document does not present a table of acceptance criteria in the manner you might expect for a diagnostic AI device. Instead, "acceptance criteria" are implicitly met by demonstrating that the device performs equivalently to the predicates in specific engineering tests.
The document states that performance data relied upon "include: biocompatibility referenced from K133460, K110658, K092038, and K193633; moist heat sterilization (to be performed by the end user) also referenced from K133460, K110658, and K193633; X-ray beam sterilization, packaging, and sterile barrier shelf life referenced from K191848 and K 193633; and mechanical testing according to ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws."
This implies that the "acceptance criteria" are compliance with recognized standards and demonstrated equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Conformance to established safety standards for medical implants. | Referenced from predicate devices K133460, K110658, K092038, and K193633, implying the subject devices, made of identical materials (ASTM F136 titanium alloy, ASTM F138 stainless steel), meet these standards. |
| Sterilization (Moist Heat, X-ray Beam): Effectiveness of sterilization methods. | Referenced from predicate devices K133460, K110658, K193633, and K191848. This indicates the devices can be effectively sterilized (by end-user for moist heat, or previously validated methods for X-ray beam applied to similar products). |
| Packaging & Sterile Barrier Shelf Life: Maintenance of sterility over time. | Referenced from predicate devices K191848 and K193633, implying the packaging and sterile barrier design for the new devices are sufficient, likely supported by similar packaging materials and designs. |
| Mechanical Performance: Structural integrity and functionality of the bone screws. | Tested according to ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws. The conclusion states, "The data included in this submission demonstrate substantial equivalence to the predicate devices listed above," implying that mechanical performance was comparable or acceptable per the standard. |
| Material Composition: Use of medically appropriate and safe materials. | Manufactured from titanium alloy conforming to ASTM F136 and stainless steel conforming to ASTM F138, which are standard materials for surgical implants. |
| Indications for Use: Alignment with predicate device's intended use. | "The subject devices are substantially equivalent in indications and design principles to the primary predicate device and the additional predicates devices listed above." Small language differences in IFU were deemed not to impact substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to non-clinical testing (biocompatibility, sterilization, mechanical testing). For such tests, the "sample size" is typically defined by the requirements of the specific ASTM standards or other test protocols. The document does not specify the exact number of devices tested for each non-clinical performance test (e.g., how many screws were subjected to ASTM F543).
- Data Provenance: The document does not specify the country of origin for the non-clinical test data. Given Medartis AG is based in Switzerland and their consultant PaxMed International, LLC is in the USA, it's likely the testing was conducted in ISO-accredited labs in one of these regions or globally. The data would be considered prospective in the sense that the tests were conducted specifically for this submission to demonstrate the device's characteristics against a standard or predicate.
- Clinical data: The document explicitly states: "Clinical data were not provided in this submission." Therefore, there is no "test set" of patient data for clinical evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Since no clinical data was provided and the evaluation relies on non-clinical testing and substantial equivalence to predicates, there was no "ground truth" to be established by clinical experts in the context of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there was no clinical test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a bone fixation fastener and K-wire system, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data, the "ground truth" or reference is established by recognized industry standards (e.g., ASTM F543) and the established safety and effectiveness profile of the predicate devices. The mechanical properties are compared against benchmark values or the performance of the predicate. Biocompatibility relies on the known properties of the materials used in accordance with established standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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November 6, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Medartis AG % Lauren M. Wessell RA Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K202589
Trade/Device Name: APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTY, HTN Dated: September 8, 2020 Received: September 8, 2020
Dear Lauren M. Wessell:
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. 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 located 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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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.
Shumaya Ali, MPH 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
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
APTUS® Cannulated Compression Screws and APTUS® headed Cannulated Compression Screws
Indications for Use (Describe)
APTUS® Cannulated Compression Screws and headed Cannulated Compression Screws are intended for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size.
Type of Use (Select one or both, as applicable)
X 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."
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Indications for Use
510(k) Number (if known)
Device Name APTUS® K-Wire System
Indications for Use (Describe)
APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.
X 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."
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510(k) Summary
APTUS® headed Cannulated Compression Screws
APTUS® Cannulated Compression Screws
APTUS® K-Wire System
Medartis AG
November 6, 2020
ADMINISTRATIVE INFORMATION Manufacturer Name Medartis AG Hochbergerstrasse 60E CH-4057 Basel, Switzerland Telephone: Official Contact Andrea Kiefer-Schweizer Head of Quality Management and Regulatory Affairs Lauren M. Wessell, RAC Representative/Consultant Kevin A. Thomas, PhD; Floyd G. Larson, MS, MBA PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: +1 858-792-1235 +1 858-792-1236 Fax: Email: lwessell(@paxmed.com kthomas(@paxmed.com; flarson(@paxmed.com DEVICE NAME AND CLASSIFICATION
| Trade/Device Name | APTUS® headed Cannulated Compression Screws |
|---|---|
| APTUS® Cannulated Compression Screws | |
| APTUS® K-Wire System | |
| Common Name | Screw, Fixation, Bone (Primary) |
| Pin, Fixation, Smooth | |
| Washer, Bolt Nut | |
| Regulation Number | 21 CFR 888.3040 (Primary) |
| 21 CFR 888.3030 | |
| Regulation Name | Smooth or threaded metallic bone fixation fastener (Primary) |
| Regulatory Class | Class II |
| Product Code | HWC (Primary), HTY, HTN |
| Classification Panel | Orthopedic |
| Reviewing Division | Office of Orthopedic Devices (OHT6) |
| Division of Restorative, Repair and Trauma Devices (DHT6C) | |
| Stereotaxic, Bone Growth Stimulators and Fracture Fixation Device | |
| Team |
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PREDICATE DEVICE INFORMATION
Primary Predicate
K133460, APTUS® Cannulated Compression Screws, Medartis AG
Additional Predicates
K110658, APTUS® Cannulated Compression Screws, Medartis AG K092038, APTUS® K-Wire System, Medartis AG K050681, Omnitech System & Easy Lock Osteosystem with Xtremities Plates, TriMed, Inc. K963192, Synthes Sterile 3.5 mm and 4.0 mm Cannulated Screws, Synthes (USA)
Reference Devices
K193633, APTUS Ankle Trauma System 2.8/3.5, Medartis AG K191848, APTUS Wrist Spanning Plates 2.5, Medartis AG
INDICATIONS FOR USE STATEMENT
APTUS® Cannulated Compression Screws and headed Cannulated Compression Screws are intended for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size.
APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.
SUBJECT DEVICE DESCRIPTION
The subject device includes APTUS Cannulated Compression Screws in thread diameters 1.7 mm, 2.2 mm, 3.0 mm, 5.0 mm, and APTUS headed Cannulated Compression Screws in diameters 2.2 mm, 3.0 mm, 5.0 mm, and 7.0 mm. APTUS Cannulated Compression Screws are headless screws that incorporate threads with different pitch on the head and tip of the screws; this difference in pitch provides compression as the screw is inserted. APTUS headed Cannulated Compression Screws have conventional bone screw heads that apply compression between the threads and the head. Both types of screws provide compression of the bone segments upon insertion of the screw. Additionally, all subject device screws have a triangular SpeedTip® shape designed to improve cutting and insertion torque and an internal hexalobular instrument face.
The APTUS Cannulated Compression Screws and APTUS headed Cannulated Compression Screws come in partially threaded and fully threaded designs. The 1.7 mm diameter screws are provided in overall lengths ranging from 8 mm to 20 mm. The 2.2 mm diameter screw are provided in overall lengths ranging from 10 mm to 40 mm. The 3.0 mm diameter screws are provided in overall lengths ranging from 10 mm to 40 mm. The 4.0 mm diameter screws are provided in overall lengths ranging from 16 mm to 60 mm. The 5.0 mm diameter screws are provided in overall lengths ranging from 24 mm to 70 mm. The 7.0 mm diameter screws are provided in overall lengths ranging from 30 mm to 140 mm.
The subject device 1.7 mm, 2.2 mm, 4.0 mm, 5.0 mm, and 7.0 mm thread diameter APTUS Cannulated Compression Screws and APTUS headed Cannulated Compression screws are used with the corresponding subject device K-wires (0.6, 0.8, 1.1, 1.25, 1.6, and 2.2 mm, respectively). The subject device screws also are compatible with the Medartis K-wires cleared under K092038. Similarly, the subject device K-wires are compatible with the APTUS Cannulated Compression Screws cleared under K133460 and K110658.
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This submission also includes the corresponding washers for APTUS headed Cannulated Compression Screws.
The subject device cannulated compression screws and washers are manufactured from titanium allov conforming to ASTM F136 Standard Specification for Wrought Titanium-61 anadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The subject device K-wires 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).
All subject devices are provided non-sterile to the end user. The subject devices are single-use only.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility referenced from K133460, K110658, K092038, and K193633; moist heat sterilization (to be performed by the end user) also referenced from K133460, K110658, and K193633; X-ray beam sterilization, packaging, and sterile barrier shelf life referenced from K191848 and K 193633; and mechanical testing according to ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws. Clinical data were not provided in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject devices are substantially equivalent in indications and design principles to the primary predicate device and the additional predicates devices listed above. Additionally, the subject devices have similar technological characteristics as the reference devices.
The subject device APTUS Cannulated Compression Screws and APTUS headed Cannulated Compression Screws have similar Indications for Use Statements (IFUS) to those of devices previously cleared in K133460, K110658, K050681, and K963192. Differences among the IFUS include specific language not in the subject device IFUS: children and adolescent patient populations (K963192), specific anatomical locations (K050681), and references to "small bones" (K050681 and K963192). These differences do not impact the substantial equivalence because all IFUS express equivalent intended use for the treatment of fractures, osteotomies and arthrodesis of bones.
The primary predicate K133460, and additional predicates K110658 and K092038, are in support of substantial equivalence in terms of comparable cannulated compression screw and K-wire designs, compatible cannulated compression screws and K-wires, and identical materials (titanium alloy conforming to ASTM F136 and stainless steel conforming to ASTM F138).
Additional predicate devices K050681 and K963192 are in support of substantial equivalence in terms of comparable screw designs and for comparative mechanical properties.
The reference device K193633 is in support of substantial equivalence for comparable washer designs and identical material (titanium alloy conforming to ASTM F136). Furthermore, the device-specific accessories and Class I instruments have similar designs and are made of identical materials as the Class II accessories and instruments previously cleared in K193633.
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The reference devices K191848 and K193633 are in support of substantial equivalence for terminal sterilization and shelf life for product provided sterile to the end user. Additionally, reference devices K191848 and K193633 are in support of identical materials for Class II device-specific accessories and Class I instruments supplied non-sterile to the end-user
CONCLUSION
The subject devices, the primary predicate device, and the additional predicate devices have the same intended use and similar technological characteristics. They encompass a similar range of physical dimensions, are manufactured from the same materials, and are to be sterilized using identical methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.