(119 days)
No
The 510(k) summary describes a mechanical bone screw with an expandable thread crest. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies focus on mechanical properties and bone interaction, not algorithmic performance.
No
The device is a bone screw used for fixation and reconstruction, not for treating diseases or conditions in a therapeutic manner.
No
Explanation: The device is a bone screw used for fixation and repair during orthopedic surgery, which falls under therapeutic or assistive devices, not diagnostic. Its intended use is described as "implantation into prepared bone during orthopaedic surgery when the surgeon determines the need for additional fixation: bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation." There is no mention of it being used to identify or detect a disease or condition.
No
The device is a physical bone screw made of titanium alloy, not software. The description details its material, dimensions, and mechanical properties, and the performance studies involve physical testing.
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 states the device is for implantation into bone during orthopedic surgery for various fixation and repair purposes. This is a surgical implant, not a device used to examine specimens from the human body.
- Device Description: The description details a physical bone screw made of titanium alloy with an expandable thread. This is a mechanical device for structural support.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) or to provide information about a person's health status based on such analysis.
IVD devices are used in vitro (outside the body) to examine specimens and provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The ACTIVE TM Screw Bone Screw is intended for implantation into prepared bone during orthopaedic surgery when the surgeon determines the need for additional fixation: bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
The ACTIVE™ Screw Bone Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Product codes
HWC
Device Description
The ACTIVE ™ Screw Bone Screws subjected to this premarket notification are 4.5 mm diameter screws available in 5 mm length increments from 20 to 50 mm. The screws are manufactured from titanium alloy and have an expandable thread crest. The implants are single use only devices.
The ACTIVE ™ Screw Bone Screw consists of a screw shank in conjunction with a spiral helical thread crest component. With the spiral helical thread component, the screw has the ability to expand an additional 1 mm after implantation.
The ACTIVE TM Screw Bone Screw is made of wrought titanium 6AI-4V ELI (ASTM F136) and is available in a 4.5 mm diameter size from 20 mm to 50 mm and will be provided non-sterile, and is to be steam sterilized by the end user. Resterilization of screws upon contamination is not recommended.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopaedic surgeon
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)
Torsion testing was conducted according to the standard bone screw testing method (Method A1 in ASTM F543-07) and the torsional strength and breaking angle exceeded the minimum required values for comparable screws of the same size. In addition, axial pullout strength testing and torque in/ torque out testing were conducted on the ACTIVE™ Screw Bone Screw and the results were acceptable.
Additional evaluation and testing was undertaken to determine the forces exerted on the bone after implantation of the helical thread crest component and the damage that the removal of the thread crest component may inflict on the surrounding bone. The forces were found to be physiologically safe to the bone and the damage generated by the removal of the thread crest component did not exceed damage resulting from the removal of a traditional (predicate) bone screw.
In all instances, the ACTIVE™ Screw Bone Screw functioned as intended and the testing results observed were acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K961157 - Whiteside Biomechanics Cancellous Bone Screw, K102429, K112772 - Wright Medical Technology ORTHOLOCTM Bone Screws, K061621 - Synthes (USA) 6.5 mm Cancellous Screws
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
K121682(Y3)
ОСТ 4 2012
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510(k) SUMMARY
Intelligent Implant Systems's ACTIVE™ Screw Bone Screw
| Company Name: | Intelligent Implant Systems, LLC |
|---|---|
| 3300 International Airport Drive, Suite 1100 | |
| Charlotte, NC 28208 | |
| (704) 424-1009 | |
| (704) 424-1011 (fax) |
| 510(k) Contact: | Michael Nutt |
|---|---|
| Chief Operations Officer | |
| (704) 424-1009 |
| Date Prepared: | August 30, 2012 |
|---|---|
| Proprietary Name: | ACTIVETM Screw Bone Screw |
| Common Name: | Bone Screw |
| Classification: | 21 CFR 888.3040 - Class II |
| Device Product Code: | HWC: Screw, Fixation Bone |
| 87 Orthopedics | |
| Predicate Devices: | K961157 - Whiteside Biomechanics Cancellous Bone |
| Screw, K102429, K112772 - Wright Medical Technology | |
| ORTHOLOCTM Bone Screws, K061621 - Synthes (USA) | |
| 6.5 mm Cancellous Screws |
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Device Description:
The ACTIVE ™ Screw Bone Screws subjected to this premarket notification are 4.5 mm diameter screws available in 5 mm length increments from 20 to 50 mm. The screws are manufactured from titanium alloy and have an expandable thread crest. The implants are single use only devices.
Intended Use / Indications for Use
The ACTIVE TM Screw Bone Screw is intended for implantation into prepared bone during orthopaedic surgery when the surgeon determines the need for additional fixation: bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
The ACTIVE™ Screw Bone Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Technological Characteristics
The ACTIVE ™ Screw Bone Screw consists of a screw shank in conjunction with a spiral helical thread crest component. With the spiral helical thread component, the screw has the ability to expand an additional 1 mm after implantation.
The ACTIVE TM Screw Bone Screw is made of wrought titanium 6AI-4V ELI (ASTM F136) and is available in a 4.5 mm diameter size from 20 mm to 50 mm and will be provided non-sterile, and is to be steam sterilized by the end user. Resterilization of screws upon contamination is not recommended.
Performance Data
Torsion testing was conducted according to the standard bone screw testing method (Method A1 in ASTM F543-07) and the torsional strength and breaking angle exceeded the minimum required values for comparable screws of the same size. In addition, axial pullout strength testing and torque in/ torque out testing were conducted on the ACTIVE™ Screw Bone Screw and the results were acceptable.
Additional evaluation and testing was undertaken to determine the forces exerted on the bone after implantation of the helical thread crest component and the damage that the removal of the thread crest component may inflict on the surrounding bone. The forces were found to be physiologically safe to the bone and the damage generated by the removal of the thread crest component did not exceed damage resulting from the removal of a traditional (predicate) bone screw.
In all instances, the ACTIVE™ Screw Bone Screw functioned as intended and the testing results observed were acceptable.
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Substantial Equivalence
The ACTIVE ™ Screw Bone Screw is substantially equivalent in design and function to the bone screws marketed by Wright Medical Technology (K102429, K112772), Whiteside Biomechanics (K961157), and Synthes (USA) (K061621). Like the predicate devices, the subject screw is composed of titanium alloy and is used in the same applications where the surgeon determines the need for additional fixation.
Substantial equivalence is shown through mechanical testing, materials information, and comparison of design characteristics. The results show that the subject ACTIVETM Screw Bone Screw can be expected to perform at least as well as the legally marketed predicate ORTHOLOC™ Bone screws, Whiteside Biomechanics Bone Screws, and Synthes (USA) Cancellous Screws
The performance data demonstrate the ACTIVE ™ Screw Bone Screw is as safe and effective as the predicate devices. The ACTIVE ™ Screw Bone Screw has the same or similar intended uses and indications, technological characteristics, and principles of operation as its predicate devices. The differences between the ACTIVE ™ Screw Bone Screw and its predicate devices raise no new issues of safety or effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 4 2012
Intelligent Implant Systems, LLC % Mr. Michael J. Nutt Chief Operating Officer 3300 International Airport Drive, Suite 100 Charlotte, North Carolina 28208
Re: K121682
Trade/Device Name: Active Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 30, 2012 Received: August 31, 2012
Dear Mr. Nutt:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
sincerely yours,
for
J. N. Mall
Mark N. Melker Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K121682
Device Name: ACTIVETM Screw Bone Screw
Intended Use:
The ACTIVE TM Screw Bone Screw is intended for implantation into prepared bone during orthopaedic surgery when the surgeon determines the need for additional fixation: bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Indications for Use:
The ACTIVE™ Screw Bone Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K121682 510(k) Number