(170 days)
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.
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.
The provided document is a 510(k) summary for the AxSOS 3 Ti device, a metallic bone fixation appliance. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical efficacy studies. Therefore, it does not contain the detailed information typically found in studies designed to prove a device meets specific acceptance criteria for performance in a clinical setting.
Based on the information provided, here's what can be inferred and what is not available:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document in the format of a table with specific acceptance criteria and reported device performance. The document states that "Bench testing was conducted comparing the cleared plates and screws with the Variable Angle Extension Arms against the predicate and reference devices." It also lists specific tests related to MR compatibility.
- Acceptance Criteria Mentioned (Implicit/General): The implicit acceptance criterion is "substantial equivalence" to the predicate device in terms of design, indications for use, technological characteristics, and performance characteristics.
- Reported Device Performance (Implicit/General): "Testing demonstrated that the subject device is substantially equivalent to the marketed predicate device."
For MR compatibility testing, the document lists the types of tests performed:
- 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
However, the specific numerical results of these tests and the acceptance thresholds are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample size for the bench testing. It refers to "cleared plates and screws with the Variable Angle Extension Arms" implying a set of device components were tested, but no numbers are given.
- Data Provenance: The data provenance for the bench testing is not specified beyond it being "bench testing." It is not clinical data, so country of origin or retrospective/prospective nature is not applicable in the typical sense.
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)
This information is not applicable or provided. Since this is a 510(k) submission primarily relying on bench testing for substantial equivalence, clinical ground truth establishment by medical experts is not discussed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable or provided. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts. Since this is bench testing, such a method would not be relevant.
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
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
- Effect Size: Therefore, no effect size of human readers improving with or without AI assistance is provided or applicable. The device is a bone fixation appliance, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The AxSOS 3 Ti device is a physical medical implant, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined in clinical or AI studies (e.g., expert consensus, pathology) is not directly applicable to this 510(k) submission which focuses on the physical and mechanical properties of an implant. The "truth" in this context is established through engineering and materials standards (e.g., ASTM standards) and direct comparison to a predicate device's established performance through bench testing.
8. The sample size for the training set
This information is not applicable or provided. As this is a physical medical device and not an AI/ML algorithm, there is no "training set" in the computational sense.
9. How the ground truth for the training set was established
This information is not applicable or provided for the same reason as point 8.
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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
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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
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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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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 componentmetallic bone fixation appliances and accessories |
| 21 CFR 888.3040: Smooth or threaded metallic bonefasteners | |
| Product Code: | HRS, HWC |
| Device Class: | Class II |
| Sponsor: | Stryker GmbHBohnackerweg 12545 Selzach / Switzerland |
| Contact Person: | Saad AttiyahSr. Regulatory Affairs ManagerBohnackerweg 12545 Selzach, Switzerlandsaad.attiyah@stryker.comPhone: 201.831.5655 |
| Date Prepared: | April 23, 2018 |
| Primary Predicate: | AxSOS 3 Ti System (K172350) |
| Reference Predicate: | Synthes 3.5mm Locking Attachment Plate(K083573) |
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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
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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.
§ 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.