(266 days)
Not Found
No
The summary describes a mechanical implant (screw system) and its performance testing, with no mention of software, algorithms, or AI/ML terms.
No.
The device is used for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, but it is not explicitly stated to be a therapeutic device. Instead, it seems to be an orthopedic implant.
No.
The "Intended Use / Indications for Use" section describes the device's function as being for surgical procedures like "bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation," which are therapeutic interventions, not diagnostic activities.
No
The device description clearly states it includes "cannulated, partially threaded bone screws," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The ActivOrtho Nitinol Compression Screw System is a surgical implant used for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation. It is a physical device implanted into the body to provide structural support and stability to bones.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens taken from the patient.
Therefore, based on the provided information, the ActivOrtho Nitinol Compression Screw System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ActivOrtho Nitinol Compression Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of small bones and small bone fragments.
Product codes
HWC
Device Description
The ActivOrtho Nitinol Compression Screw System includes cannulated, partially threaded bone screws having a 4mm diameter in a variety of lengths to accommodate various applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and small bone fragments
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)
Torsional properties, driving torque and axial pullout strength testing was performed on a worst case device according to ASTM F543. In addition, corrosion susceptibility testing was performed per ASTM F2129.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K160427, K963192, K973309, K102903
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 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 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.
March 12, 2019
ActivOrtho, Inc. % Karen Warden Representative/Consultant BackRoads Consulting, Inc. PO Box 566 Chesterland, Ohio 44026-0566
Re: K181610
Trade/Device Name: ActivOrtho Nitinol Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 29, 2019 Received: January 31, 2019
Dear Karen Warden:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 mediation-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,
Shumaya Ali -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K181610
Device Name
ActivOrtho Nitinol Compression Screw System
Indications for Use (Describe)
The ActivOrtho Nitinol Compression Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of small bones and small bone fragments.
| 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
| Date: | 8 March 2019 |
|---|---|
| Sponsor: | ActivOrtho, Inc. |
| 12820 34th Ave N | |
| Plymouth, MN 55441 | |
| Phone: 651-341-3805 | |
| Sponsor Contact: | Paul Hindrichs |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting, Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Names: | ActivOrtho Nitinol Compression Screw System |
| Common Name: | Bone screw |
| Regulatory Class: | Class II |
| Classification Name / | |
| Regulation / Product | |
| Code: | Smooth or threaded metallic bone fixation fastener / 888.3040 / HWC |
| Device Description: | The ActivOrtho Nitinol Compression Screw System includes cannulated, |
| partially threaded bone screws having a 4mm diameter in a variety of | |
| lengths to accommodate various applications. | |
| Indications for Use: | The ActivOrtho Nitinol Compression Screw System is indicated for use in |
| bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair | |
| and fracture fixation of small bones and small bone fragments. | |
| Materials: | The ActivOrtho Nitinol Compression Screw implants are made from Nitinol |
| (ASTM F2063). | |
| Primary Predicate: | dynaMXTM Nitinol Compression Screw (MX Orthopedics Corporation -- |
| K160427) | |
| Additional | |
| Predicates: | Synthes 4.0 Cannulated Screw (Synthes USA - K963192); Vilex |
| Cannulated Bone Screw (Vilex Inc. - K973309), Zimmer Cannulated Screw | |
| System (Pioneer Surgical Technology - K102903) | |
| Performance Data: | Torsional properties, driving torque and axial pullout strength testing was |
| performed on a worst case device according to ASTM F543. In addition, | |
| corrosion susceptibility testing was performed per ASTM F2129. | |
| Technological | |
| Characteristics: | The ActivOrtho Nitinol Compression Screw System possesses the same |
| technological characteristics as one or more of the predicate devices. | |
| These include, performance, basic design, material, method of stabilization | |
| and sizes (dimensions are comparable to those offered by the predicate | |
| systems). | |
| While the ActivOrtho Nitinol Compression Screw System is not identical to | |
| the predicate devices, the differences were shown not to raise new | |
| questions of safety and effectiveness. Therefore the fundamental scientific | |
| technology of the ActivOrtho Nitinol Compression Screw System is similar | |
| to previously cleared devices. | |
| Conclusion: | The ActivOrtho Nitinol Compression Screw System possesses indications |
| for use the same as and technological characteristics similar to the | |
| predicate devices. Therefore the ActivOrtho Nitinol Compression Screw | |
| System is substantially equivalent to the predicates. |