(108 days)
Not Found
No
The 510(k) summary describes a system of plates, screws, and instruments for bone fixation and arthrodesis. There is no mention of software, algorithms, image processing, AI, or ML. The performance studies focus on mechanical testing and MRI compatibility.
Yes
The device is used for arthrodesis and fracture fixation, which are direct treatments for musculoskeletal conditions.
No
The device is an internal fixation system (plates and screws) used for arthrodesis and fracture fixation, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is an "internal fixation system composed of sterile and non-sterile plates, and associated instruments" and "sterile and non-sterile plates, screws, and complementary, implantable devices, along with associated instruments." This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for arthrodesis (fusion) and fracture fixation of bones in the ankle, long bones, scapula, and pelvis. These are surgical procedures performed directly on the patient's body.
- Device Description: The device is described as an internal fixation system composed of plates, screws, and instruments. These are implants and tools used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
In summary, the AxSOS 3 Ankle Fusion System and AxSOS 3 Ti are surgical implants and instruments used for orthopedic procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AxSOS 3 Ankle Fusion System is indicated for arthrodesis of the includes tibio-talo-calcaneal, tibiotalar, and tibio-calcaneal arthrodesis, in possible conjunction with osteotomies of the distal tibia, talus, and calcaneus.
AxSOS 3 Ti is intended for long bone fracture fixation.
Indications include:
- · Diaphyseal, metaphyseal, extra- and intra-articular fractures
- · Non-unions and malunions
- · Normal and osteopenic bone
- · Osteotomies
- · Periprosthetic fractures of the femur and proximal tibia
The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:
- · Periprosthetic fractures
- · Diaphyseal and metaphyseal areas of long bones in pediatric patients
The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
Screws can also be used for arthrodesis.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
AxSOS 3 AF (Ankle Fusion) is an internal fixation system composed of sterile and non-sterile plates, and associated instruments. These plates are available in a variety of anatomical orientations and made of titanium alloy, with Type II anodization, and used with compatible screws.
AxSOS 3 Ti is an internal fixation system composed of sterile and non-sterile plates, screws, and complementary, implantable devices, along with associated instruments. The plates are available in a variety of anatomical orientations and lengths. Implants of this system are available in titanium alloy, with Type II anodization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle (tibio-talo-calcaneal, tibio-talar, and tibio-calcaneal), distal tibia, talus, calcaneus, long bones (diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures, femur, proximal tibia), scapula, pelvis.
Indicated Patient Age Range
pediatric patients (for AxSOS 3 Ti Waisted Compression Plates on diaphyseal and metaphyseal areas of long bones)
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)
Non-Clinical Testing:
Comparative, mechanical testing to predicate devices demonstrated substantial equivalence:
Screws were tested per ASTM F543
- Pull-Out
- . Torsional Strength
- . Insertion Torque
Screw-plate constructs were tested using axial compression bending fatigue.
Tests performed to establish compatibility with a magnetic resonance environment:
- Induced Displacement
- Induced Torque
- RF Heating
- . Image Artifacts
Clinical Testing:
Clinical testing was not a requirement for this submission.
Key Results:
Performance testing established that these do not hinder subject devices from performing at least as well as the predicates, thus demonstrating that the subject devices are safe and effective.
Mechanical testing demonstrated the performance of the proposed devices is equivalent to the predicate devices.
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.
K163650, K181091, K024060, K050512, K190586
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
June 5, 2020
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" in blue, with the word "ADMINISTRATION" underneath.
Stryker GmbH Paul Nelson Staff Specialist, Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430
Re: K200398
Trade/Device Name: AxSOS 3 AF System and AxSOS 3 Ti 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: Mav 22, 2020 Received: May 27, 2020
Dear Paul Nelson:
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.
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
1
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 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,
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
2
Indications for Use
510(k) Number (if known) K200398
Device Name AxSOS 3 AF System
Indications for Use (Describe)
The AxSOS 3 Ankle Fusion System is indicated for arthrodesis of the includes tibio-talo-calcaneal, tibiotalar, and tibio-calcaneal arthrodesis, in possible conjunction with osteotomies of the distal tibia, talus, and calcaneus.
| 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
Indications for Use
510(k) Number (if known) K200398
Device Name AxSOS 3 Ti System
Indications for Use (Describe) AxSOS 3 Ti is intended for long bone fracture fixation.
Indications include:
- · Diaphyseal, metaphyseal, extra- and intra-articular fractures
- · Non-unions and malunions
- · Normal and osteopenic bone
- · Osteotomies
- · Periprosthetic fractures of the femur and proximal tibia
The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:
- · Periprosthetic fractures
- · Diaphyseal and metaphyseal areas of long bones in pediatric patients
The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
Screws can also be used for arthrodesis.
| 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."
4
510(k) Summary
| Submitter: | Stryker GmbH
Bohnackerweg 1
CH-2545 Selzach
Switzerland |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paul Nelson
Staff Specialist, Regulatory Affairs
Phone: (201) 831-5691
Fax: (201) 831-6500 |
| Date Prepared: | February 7, 2018 |
| Name of Device: | AxSOS 3 AF System
AxSOS 3 Ti System |
| Common or Usual Name: | Plate, Fixation, Bone |
| | Screw, Fixation, Bone |
| Classification Name: | AxSOS 3 AF System
Single/multiple component metallic bone fixation appliances
and accessories
21 CFR § 888.3030 (primary) |
| | Smooth or threaded metallic bone fixation fastener
21 CFR § 888.3040 |
| | AxSOS 3 Ti System
Single/multiple component metallic bone fixation appliances
and accessories
21 CFR § 888.3030 (primary) |
| | Smooth or threaded metallic bone fixation fastener
21 CFR § 888.3040 |
| Regulatory Class: | Class II |
| Product Codes: | AxSOS 3 AF System
HRS, HWC |
| | AxSOS 3 Ti System
HRS, HWC |
| Primary Predicate: | AxSOS 3 AF System
Ortholoc 3Di Ankle Fusion Plating System, K163650 |
| | AxSOS 3 Ti System
AxSOS 3 Ti System, K181091 |
| Additional Predicate: | AxSOS 3 Ti System |
5
Asnis III Cannulated Screw System, K024060 Stryker Locked Plating System, K050512 Monster Screw System, K190586
Description:
AxSOS 3 AF System
AxSOS 3 AF (Ankle Fusion) is an internal fixation system composed of sterile and non-sterile plates, and associated instruments. These plates are available in a variety of anatomical orientations and made of titanium alloy, with Type II anodization, and used with compatible screws.
AxSOS 3 Ti System
AxSOS 3 Ti is an internal fixation system composed of sterile and non-sterile plates, screws, and complementary, implantable devices, along with associated instruments. The plates are available in a variety of anatomical orientations and lengths. Implants of this system are available in titanium alloy, with Type II anodization.
Indications for Use:
AxSOS 3 AF System
The AxSOS 3 Ankle Fusion System is indicated for arthrodesis of the ankle, which includes tibio-talocalcaneal, tibio-talar, and tibio-calcaneal arthrodesis, in possible conjunction with osteotomies and fractures of the distal tibia, talus, and calcaneus.
AxSOS 3 Ti System
AxSOS 3 Ti is intended for long bone fracture fixation.
Indications include:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures ●
- Non-unions and malunions
- Normal and osteopenic bone
- Osteotomies
- Periprosthetic fractures of the femur and proximal tibia .
The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:
- Periprosthetic fractures ●
- Diaphyseal and metaphyseal areas of long bones in pediatric patients .
The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
Screws can also be used for arthrodesis.
Summary of Technologies:
A comparison of systems demonstrated that the subject AxSOS 3 AF and AxSOS 3 Ti systems are substantially equivalent to the previously cleared, predicate systems mentioned above when considering intended use, material, design, and operating principles.
6
The subject and predicate devices for both AxSOS 3 Ti systems utilize the same general technological and design characteristics found in plate and screw device types to achieve the same intended use of bony tissue fixation. In addition, where applicable, these devices contain geometries allowing for a screw locking mechanism. Among these systems is also the use of titanium alloy.
The subject and predicate devices for both AxSOS 3 AF and AxSOS 3 Ti systems do differ on specific design feature geometries and dimensions. Performance testing established that these do not hinder subject devices from performing at least as well as the predicates, thus demonstrating that the subject devices are safe and effective.
Performance Data:
Non-Clinical Testing
Comparative, mechanical testing to predicate devices demonstrated substantial equivalence:
Screws were tested per ASTM F543
- Pull-Out
- . Torsional Strength
- . Insertion Torque
Screw-plate constructs were tested using axial compression bending fatigue.
Tests performed to establish compatibility with a magnetic resonance environment:
- Induced Displacement
- Induced Torque
- RF Heating
- . Image Artifacts
Clinical Testing
Clinical testing was not a requirement for this submission.
Conclusion:
The AxSOS 3 AF and AxSOS 3 Ti subject systems have similar indications, intended use, target populations, technological characteristics, and materials as the predicate devices. Mechanical testing demonstrated the performance of the proposed devices is equivalent to the predicate devices.