(168 days)
No
The device description and performance studies focus on the mechanical properties and sterilization of the screws, with no mention of AI or ML.
Yes
The device is intended for fracture fixation and arthrodesis, which are medical treatments for conditions.
No
The device is a system of cannulated screws intended for fracture fixation and arthrodesis, which are treatments for existing conditions, not diagnostic procedures.
No
The device description explicitly states that the InFix Cannulated Screw System includes physical components (screws and washers) made of stainless steel and titanium alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "fracture fixation of various bones and bone fragments" and "fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections." This describes a surgical implant used to treat musculoskeletal conditions.
- Device Description: The description details a "cannulated screw system" made of stainless steel and titanium alloy, designed to be guided into position via a guide wire for "alignment and stabilization of fractures to the skeletal system." This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for diagnostic purposes.
Therefore, the InFix Cannulated Screw System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
InFix Cannulated Screw System is generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, metatarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. InFix Cannulated Screw System is also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections.
Accessories implants:
The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.
Product codes
HWC
Device Description
The InFix Cannulated Screw System includes eight cannulated screw specifications and associated washers, which are manufactured from stainless steel and titanium alloy. The cannulated screw is a self-tapping and self-drilling screw with a cancellous thread that can be guided into a position via a guided wire. They are used to aid in the alignment and stabilization of fractures to the skeletal system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, metatarsal, wrist, metacarpal, carpal, scaphoid and radius
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)
Non-Clinical Tests
Biomechanical Test
The biomechanical tests ASTM F543 were performed to determine substantial equivalence of the InFix Cannulated Screw System including self-tapping, torsional, axial pullout and driving torque. Results indicate that the subject screws are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
Cleaning Validation
The cleaning validation was performed in according with the AAMI TIR30:2011 guidance document. The test result shows that the acceptance criteria is met.
Sterilization Validation
The sterilization validation was performed in according with the ANSI/AAMI/ISO 17665-1. The test result shows that the acceptance criteria is met.
The InFix Cannulated Screw System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the InFix Cannulated Screw System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
Clinical Tests
Clinical data and conclusions were not needed for these devices to show substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K962011, K021932, K963172, K963192, K962823, K012945, K111678
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2015
Infix Medical, LLC Mr. James Holley Chief Operating Officer 69 Baybridge Drive, Suite M Gulf Breeze, Florida 32561
Re: K142057
Trade/Device Name: Infix Cannulated 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: November 21, 2014 Received: November 21, 2014
Dear Mr. Holley:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INFIX
Traditional 510(k) Premarket Notification
Indications for Use
510(k) Number (if known):
Device Name: InFix Cannulated Screw System
Indications for Use:
InFix Cannulated Screw System is generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. InFix Cannulated Screw System is also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections.
Accessories implants:
The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Orthopedic Devices
510(k) Number:
3
510(k) Summary
Submitter's Name: Infix Medical, LLC Address: 69 Baybridge Dr. Gulf Breeze, FL 32561 Tel: 850-324-7675 Fax: 855-228-1339
Contact Name: James C Holley
Preparation date: January, 5, 2015
Registration Number: 3010759323
Device Name: InFix Cannulated Screw System
Common Name: Bone Fixation Screws
Classification Name: Class II, as per Title 21 of the Code of Federal Regulations, Sec. 888.3040 Smooth or threaded metallic bone fixation fastener
Product Code: HWC
Predicate Device Information:
SYNTHES 7.0/7.3 MM CANNULATED SCREWS (K962011) SYNTHES 6.5 MM CANNULATED SCREWS (K021932) SYNTHES STERILE 4.5 MM CANNULATED SCREWS (K963172) SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS (K963192) SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER (K962823) SYNTHES 2.4 MM CANNULATED SCREW (K012945) ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS (K111678)
Device Description:
The InFix Cannulated Screw System includes eight cannulated screw specifications and associated washers, which are manufactured from stainless steel and titanium alloy. The cannulated screw is a self-tapping and self-drilling screw with a cancellous thread that can
4
be guided into a position via a guided wire. They are used to aid in the alignment and stabilization of fractures to the skeletal system.
Indication for use:
InFix Cannulated Screw System is generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, metatarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. InFix Cannulated Screw System is also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections.
Accessories implants:
The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.
Technological Characteristics
The technological characteristic of the InFix Cannulated Screw System are similar to the predicate devices including design, dimensions, and materials. The InFix Cannulated Screw System screws and washers are fabricated from stainless steel 316L per ASTM F138 and Ti-6Al-4V alloy per ASTM F136. The stainless steel 316L and Ti-6Al-4V are commonly used material in orthopedic implants.
Summary of Substantial Equivalence:
The InFix Cannulated Screw System is substantially equivalent to the predicated devices. No new issues of safety or efficacy have been raised.
Summary of Performance Data (Nonclinical and/or Clinical) Non-Clinical Tests
-
Biomechanical Test
The biomechanical tests ASTM F543 were performed to determine substantial equivalence of the InFix Cannulated Screw System including self-tapping, torsional, axial pullout and driving torque. Results indicate that the subject screws are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness. -
Cleaning Validation The cleaning validation was performed in according with the AAMI TIR30:2011 guidance document. The test result shows that the acceptance criteria is met.
-
Sterilization Validation
5
The sterilization validation was performed in according with the ANSI/AAMI/ISO 17665-1. The test result shows that the acceptance criteria is met.
- The InFix Cannulated Screw System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the InFix Cannulated Screw System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
Clinical Tests
Clinical data and conclusions were not needed for these devices to show substantial equivalence.
Conclusions
The InFix Cannulated Screw System has been shown to be substantially equivalent the predicate devices. Result of preclinical tests/engineering justification and the similarities with legal marketed predicated devices indicate the device will perform within the intended use and no new issues of safety or effectiveness have been raised