(21 days)
Not Found
No
The description focuses on the mechanical properties and design of a bone screw, with no mention of AI or ML.
Yes
Explanation: The device is a bone screw used for fracture repair and fixation, which falls under the definition of a therapeutic device as it directly treats a medical condition.
No
Explanation: The device is a surgical implant designed for bone reconstruction and fracture fixation, not for diagnosing medical conditions. Its purpose is therapeutic and structural.
No
The device description clearly states it is a "cannulated Nitinol bone screw" and describes its physical characteristics and mechanical properties, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description and Intended Use: The Activ Ortho Continuous Compression Screw System is a surgical implant used for bone repair and fixation within the body. It is a physical device that is surgically inserted.
- Lack of IVD Characteristics: The description and intended use do not mention any testing of biological samples, analysis of bodily fluids, or diagnostic information derived from such tests.
Therefore, based on the provided information, the Activ Ortho Continuous Compression Screw System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Activ Ortho Continuous 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 Continuous Compression Screw System is a cannulated Nitinol bone screw having various sizes to accommodate a variety of applications. The screws are headed, cannulated, and partially threaded. The continuous compression screw incorporates a helical expansion section in the smooth shaft of the screw which elongates as the distal thread engages bone to produce a continuous compression force across the fracture site.
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
Prescription Use
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. Corrosion susceptibility testing was performed according to ASTM F2129. In addition, construct static and dynamic bend testing, and compression force testing were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
July 26, 2019
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ActivOrtho. Inc. % Lisa Pritchard Regulatory, Quality & Compliance Consultant DuVal & Associates, P.A. 825 Nicollet Mall, Suite 1820 Minneapolis, Minnesota 55402
Re: K191817
Trade/Device Name: ActivOrtho Continuous 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: July 3, 2019 Received: July 5, 2019
Dear Lisa Pritchard:
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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542 of the Act); 21 CFR 1000-1050.
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 (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-
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191817
Device Name
ActivOrtho Continuous Compression Screw System
Indications for Use (Describe)
The Activ Ortho Continuous 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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510(K) SUMMARY
1. SUBMITTER
ActivOrtho, Inc. 14405 21st Ave N. Suite 120 Plymouth, MN 55447 Phone: 651.341.3805 Contact Person: Paul Hindrichs Date Prepared: July 26, 2019
2. DEVICE
Name of Device: ActivOrtho Continuous Compression Screw System Common or Usual Name: Bone Screw Classification Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC
3. PREDICATE DEVICE
Primary Predicate: ActivOrtho Nitinol Compression Screw System, K181610 Additional Predicate 1: dynaMX™ Nitinol Compression Screw, K160427 Additional Predicate 2: Synthes 4.0 Cannulated Screw, K963192 These predicates have not been subject to a design-related recall.
4. DEVICE DESCRIPTION
The ActivOrtho Continuous Compression Screw System is a cannulated Nitinol bone screw having various sizes to accommodate a variety of applications. The screws are headed, cannulated, and partially threaded. The continuous compression screw incorporates a helical expansion section in the smooth shaft of the screw which elongates as the distal thread engages bone to produce a continuous compression force across the fracture site.
5. INDICATIONS FOR USE
The ActivOrtho Continuous 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.
6. MATERIALS
The ActivOrtho Continuous Compression Screw implants are made from Nitinol (ASTM F2063)
7. PRIMARY PREDICATE DEVICE
ActivOrtho Nitinol Compression Screw (ActivOrtho, Inc. - K181610)
8. ADDITIONAL PREDICATE DEVICES
dynaMX Nitinol Compression Screw (MX Orthopedics Corporation - K160427)
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Synthes 4.0 Cannulated Screw (Synthes USA - K963192)
9. NON-CLINICAL PERFORMANCE DATA
Torsional properties, driving torque and axial pullout strength testing was performed on a worst-case device according to ASTM F543. Corrosion susceptibility testing was performed according to ASTM F2129. In addition, construct static and dynamic bend testing, and compression force testing were performed.
10. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The ActivOrtho Continuous 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). The ActivOrtho Continuous Compression Screw and the primary predicate device are manufactured from the same material, are cannulated, have the same lengths, and same screw thread geometry,
The ActivOrtho Continuous Compression Screw includes a helical expansion section in the smooth shaft of the screw that is not present on the predicate devices. While the ActivOrtho Continuous 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 Continuous Compression Screw System is similar to previously cleared devices.
11. CONCLUSION
The ActivOrtho Continuous Compression Screw System possesses the same intended use and has technological characteristic similar to the predicate devices. Therefore, the ActivOrtho Continuous Compression Screw System is substantially equivalent to the predicates.