(170 days)
No
The document describes a traditional orthopedic implant system and an additional component. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are bench tests related to mechanical properties and MR compatibility.
Yes
The device is described as an "internal fixation system" used for "long bone fracture fixation," "non-unions and malunions," and "osteotomies," which are all therapeutic interventions.
No
Explanation: The device is an internal fixation system for long bone fractures and osteotomies; it is not used to diagnose a condition.
No
The device description clearly states that the AxSOS 3 Ti system includes physical components such as plates, screws, blind screws, and auxiliary components made from titanium alloy. The submission also introduces a new physical component, the Variable Angle Extension Arm connector, made from anodized titanium and Co-Cr. This is a hardware-based medical device for internal fixation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "long bone fracture fixation" and lists various types of fractures and bone conditions. This is a surgical implant used to treat physical injuries.
- Device Description: The description details plates, screws, and connectors made of titanium alloy, designed for internal fixation. These are mechanical components for surgical procedures.
- Anatomical Site: The device is used on bones (long bone, femur, tibia, scapula, pelvis).
- Intended User/Care Setting: It is a "Prescription Use" device, implying it is used in a clinical setting by medical professionals for surgical intervention.
- Performance Studies: The studies described are bench testing for mechanical properties and MR compatibility, which are relevant for surgical implants, not diagnostic tests.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a surgical implant used to stabilize fractures.
N/A
Intended Use / Indications for Use
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 from 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.
Product codes
HRS, HWC
Device Description
The AxSOS 3 Ti system (also referred to as "AxSOS 3 Ti Locking Plate System") is a system used for internal fixation applications. The system includes anatomically contoured monoaxial locking plates, screws, blind screws, and auxiliary components. The plates have been designed with holes that can accommodate either locking or non-locking screws, holes for suture and/or Kirschner wires (K-wires). The screws come in 3 types (locking, cortical, and cancellous) and are available in several different diameters and lengths. Implants can be delivered sterile or nonsterile. The various plates and screws are manufactured from titanium alloy (ASTM F-136).
This traditional 510(k) submission is intended to introduce an additional component into the AxSOS 3 Ti System. The Variable Angle Extension Arm connector is an assembly made from an anodized titanium frame (Ti-6Al-4V, ASTM F136) and Co-Cr inlay (ASTM F1537, CoCr28Mo6). These preassembled Variable Angle Extension Arms can be affixed to the previously cleared Distal Lateral Femur Plates, the 5.0 mm narrow waisted compression plates, or the 5.0 mm broad waisted compression plates. The Variable Angle Extension Arms are affixed to the plate using the 4.0 mm blind screw and use a 4.0 mm locking screw to secure it into the desired targeted location of the fragment. These Variable Angle Extension Arms are used for periprosthetic fractures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone, femur, proximal tibia, scapula, pelvis
Indicated Patient Age Range
pediatric patients
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)
Bench testing was conducted comparing the cleared plates and screws with the Variable Angle Extension Arms against the predicate and reference devices.
Testing was performed to determine the compatibility of the system in a MR environment. These tests included an assessment of:
- Magnetically Induced Displacement Force per ASTM F2052
- Magnetically Induced Torque per ASTM F2213
- Heating by RF Fields per ASTM F2182
- Image Artifacts per ASTM F2119
Testing demonstrated that the subject device is substantially equivalent to the marketed predicate device.
Animal testing was not required for this submission.
Clinical testing was not required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AxSOS 3 Ti System (K172350)
Reference Device(s)
Synthes 3.5mm Locking Attachment Plate (K083573)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Stryker GmbH Saad Attiyah Sr. Regulatory Affairs Manager Bohnackerweg 1 Selzach, 2545 Ch
October 11, 2018
Re: K181091
Trade/Device Name: AxSOS 3 Ti 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: April 23, 2018 Received: April 24, 2018
Dear Saad Attiyah:
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/cfpmp/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 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
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jesse Muir -S 2018.10.11 22:41:44 -04'00'
For:
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K181091
Device Name AxSOS 3 Ti
Indications for Use (Describe)
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 from 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.
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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3
510(k) Summary
| Proprietary Name: | AxSOS 3 Ti |
|---|---|
| Common Name: | Plate, Fixation, Bone and Screw, Fixation, Bone |
| Regulation Number & | |
| Regulation Description: | 21 CFR 888.3030: Single/multiple component |
| metallic bone fixation appliances and accessories | |
| 21 CFR 888.3040: Smooth or threaded metallic bone | |
| fasteners | |
| Product Code: | HRS, HWC |
| Device Class: | Class II |
| Sponsor: | Stryker GmbH |
| Bohnackerweg 1 | |
| 2545 Selzach / Switzerland | |
| Contact Person: | Saad Attiyah |
| Sr. Regulatory Affairs Manager | |
| Bohnackerweg 1 | |
| 2545 Selzach, Switzerland | |
| saad.attiyah@stryker.com | |
| Phone: 201.831.5655 | |
| Date Prepared: | April 23, 2018 |
| Primary Predicate: | AxSOS 3 Ti System (K172350) |
| Reference Predicate: | Synthes 3.5mm Locking Attachment Plate |
| (K083573) |
4
Description
The AxSOS 3 Ti system (also referred to as "AxSOS 3 Ti Locking Plate System") is a system used for internal fixation applications. The system includes anatomically contoured monoaxial locking plates, screws, blind screws, and auxiliary components. The plates have been designed with holes that can accommodate either locking or non-locking screws, holes for suture and/or Kirschner wires (K-wires). The screws come in 3 types (locking, cortical, and cancellous) and are available in several different diameters and lengths. Implants can be delivered sterile or nonsterile. The various plates and screws are manufactured from titanium alloy (ASTM F-136).
This traditional 510(k) submission is intended to introduce an additional component into the AxSOS 3 Ti System. The Variable Angle Extension Arm connector is an assembly made from an anodized titanium frame (Ti-6Al-4V, ASTM F136) and Co-Cr inlay (ASTM F1537, CoCr28Mo6). These preassembled Variable Angle Extension Arms can be affixed to the previously cleared Distal Lateral Femur Plates, the 5.0 mm narrow waisted compression plates, or the 5.0 mm broad waisted compression plates. The Variable Angle Extension Arms are affixed to the plate using the 4.0 mm blind screw and use a 4.0 mm locking screw to secure it into the desired targeted location of the fragment. These Variable Angle Extension Arms are used for periprosthetic fractures.
Indications for Use
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 0
- Osteotomies
- o 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
5
and the pelvis.
Summary of Technologies
A comparison of the systems demonstrated the subject AxSOS 3 Ti system is substantially equivalent to the previously cleared AxSOS 3 Ti system (K172350) with regards to intended use, design, and operational principles.
Non-Clinical Testing
Bench testing was conducted comparing the cleared plates and screws with the Variable Angle Extension Arms against the predicate and reference devices.
Testing was performed to determine the compatibility of the system in a MR environment. These tests included an assessment of:
- Magnetically Induced Displacement Force per ASTM F2052 ●
- 0 Magnetically Induced Torque per ASTM F2213
- Heating by RF Fields per ASTM F2182 ●
- Image Artifacts per ASTM F2119
Testing demonstrated that the subject device is substantially equivalent to the marketed predicate device.
Animal Testing
Animal testing was not required for this submission.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
Documentation is provided demonstrating the AxSOS 3 Ti System is substantially equivalent to the predicate and reference devices in of design, indications for use, technological characteristics, and performance characteristics.