(90 days)
Not Found
No
The document describes a purely mechanical, bioresorbable bone screw and associated instrumentation. There is no mention of software, algorithms, or any form of data processing that would suggest the use of AI or ML. The performance studies focus on mechanical properties and degradation, not algorithmic performance.
Yes.
The device is used for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses, or bone grafts, which directly addresses a medical condition or disease.
No
The device is an orthopedic implant (screw) used for internal fracture fixation, not for diagnosing medical conditions. Its purpose is to physically stabilize bone fractures and provide fixation.
No
The device description clearly states that the Inion FreedomScrew™ implants are physical internal fracture fixation devices made of degradable co-polymer. It also mentions associated physical instrumentation. There is no mention of software as the primary component or function of the device.
Based on the provided text, the Inion FreedomScrew™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts". This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a "internal fracture fixation device made of degradable co-polymer" that is "implanted". This further confirms it's a physical implant.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a physiological or pathological state
- Being used in a laboratory setting
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Inion FreedomScrew™ is a therapeutic device used to physically stabilize bone.
N/A
Intended Use / Indications for Use
The Inion FreedomScrew™ products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
In addition, the Inion FreedomScrew™ Ø3.5/4.0/4.5 mm products are specifically intended for use in following indications:
A. General indications: maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.
B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
Inion FreedomScrew™ implants are internal fracture fixation devices made of degradable co-polymer composed of 100 % poly(L-lactide-co-D,L-lactide). Based on in vitro testing, the implants retain their initial strength up to 12 weeks after implantation, and gradually lose their strength thereafter. Bioresorption takes place within two to four years.
Inion FreedomScrews™ are in the range of diameter: 2.0 - 4.5 mm and length: 10 - 90 mm. The designs include fully and partially threaded screws, as well as solid and cannulated screws. Inion FreedomScrew™ implants are used together with the previously cleared Inion OTPS™ plating systems, as well as alone according to their indications for use. The Inion FreedomScrew™ products provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.
Inion FreedomScrews™ are provided sterile to the user and are non-collagenous. The shelf life of the device is 3 years and they are intended for single use only.
The Inion FreedomScrews™ are primarily designed to be used with customized Inion instrumentation, such as drill bits, bone taps, holding sleeves, screwdriver shafts, countersinks, depth gauges, K-wires and cutting instruments, as well as with ISO 5835/ISO 9714 compatible instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fractures, osteotomies, arthrodeses or bone grafts of the upper extremity, ankle and foot; malleoli, and ankle fractures.
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)
Mechanical shear, torsion and pull-out tests were performed to verify the strength properties of Inion FreedomScrew™ implants and to compare them to the predicate devices. Mechanical fixation test was performed to verify the properties of Inion FreedomScrew™ with the Inion FreedomPlate™ and to compare them to the fixation properties of the predicate devices. Fixation tests with Inion FreedomPlate™ included the technique of removing the screw heads after insertion by cutting forceps or heat loop device, where plate-screw interface creates appropriate grip and secures fixation.
In vitro degradation testing was carried out to determine the degradation profile (i.e., change in material and mechanical properties) and verify the sufficiency of the mechanical stability over healing period as the polymer degrades during in vitro degradation and to ensure the degradation of the Inion FreedomScrews™.
- Functional and handling test and simulated clinical use test were performed to verify that the implants, accessory instruments, packaging and instructions for use are functioning together as intended, and conform to the defined user needs and intended uses. The tests were done also in comparison to the predicate devices.
The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion FreedomScrew" are substantially equivalent with the predicate devices Inion OTPS_"" Mesh System (K031961), Inion OTPS™ Mini Screws (K043142) and Inion OTPS™ Fixation System (K030900). The devices have passed the tests for functionality and handling in simulated clinical use settings and compare favourably to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K123672 (pg 1/2
510(k) SUMMARY Inion FreedomScrewTM
FEB 2 7 2013
Image /page/0/Picture/3 description: The image shows the word "INION" in bold, white letters against a black background. The letters are large and fill most of the frame. The background has a grainy texture, which contrasts with the smooth, solid letters. The overall impression is simple and graphic.
| Manufacturer and submitter: | Inion Oy,
Lääkärinkatu 2,
FIN-33520 Tampere, FINLAND |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of this summary:
Contact person | November 23, 2012
Kati Marttinen, Quality and Regulatory Director
Phone: +358 10 830 6600
Fax: +358 10 830 6691
kati.marttinen@inion.com |
| Establishment registration
number | 9710629 |
| Trade name of the device | Inion FreedomScrewTM |
| Device classification and
product code | Class II
Classification Panel: Orthopaedic
Product Code: HWC
Common name: Bone screw
Regulation number: 888.3040 |
| Predicate device | K031961
K043142
K030900 |
| Conformance with performance
standards | No applicable mandatory performance standards exist for
this device. Compliance to voluntary consensus standards is
listed in the application. |
Device description and principles of operation
Inion FreedomScrew™ implants are internal fracture fixation devices made of degradable co-polymer composed of 100 % poly(L-lactide-co-D,L-lactide). Based on in vitro testing, the implants retain their initial strength up to 12 weeks after implantation, and gradually lose their strength thereafter. Bioresorption takes place within two to four years.
Inion FreedomScrews™ are in the range of diameter: 2.0 - 4.5 mm and length: 10 - 90 mm. The designs include fully and partially threaded screws, as well as solid and cannulated screws. Inion FreedomScrew™ implants are used together with the previously cleared Inion OTPS™ plating systems, as well as alone according to their indications for use. The Inion FreedomScrew™ products provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.
Inion FreedomScrews™ are provided sterile to the user and are non-collagenous. The shelf life of the device is 3 years and they are intended for single use only.
The Inion FreedomScrews™ are primarily designed to be used with customized Inion instrumentation, such as drill bits, bone taps, holding sleeves, screwdriver shafts, countersinks, depth gauges, K-wires and cutting instruments, as well as with ISO 5835/ISO 9714 compatible instrumentation.
1
510(k) SUMMARY Inion FreedomScrew™
Image /page/1/Picture/2 description: The image shows the word "INION" in white letters against a black background. The letters are bold and sans-serif. The background appears to have a grainy or textured quality, possibly due to noise or artifacts in the image.
Indications for use
The Inion FreedomScrew™M products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
In addition, the Inion FreedomScrew™ Ø3.5/4.0/4.5 mm products are specifically intended for use in following indications:
A. General indications: maintenance of reduction of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.
B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.
Performance testing for substantial equivalence determination
Mechanical shear, torsion and pull-out tests were performed to verify the strength properties of Inion FreedomScrew™ implants and to compare them to the predicate devices. Mechanical fixation test was performed to verify the properties of Inion FreedomScrew™ with the Inion FreedomPlate™ and to compare them to the fixation properties of the predicate devices. Fixation tests with Inion FreedomPlate™ included the technique of removing the screw heads after insertion by cutting forceps or heat loop device, where plate-screw interface creates appropriate grip and secures fixation.
In vitro degradation testing was carried out to determine the degradation profile (i.e., change in material and mechanical properties) and verify the sufficiency of the mechanical stability over healing period as the polymer degrades during in vitro degradation and to ensure the degradation of the Inion FreedomScrews™.
- Functional and handling test and simulated clinical use test were performed to verify that the implants, accessory instruments, packaging and instructions for use are functioning together as intended, and conform to the defined user needs and intended uses. The tests were done also in comparison to the predicate devices.
The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion FreedomScrew" are substantially equivalent with the predicate devices Inion OTPS_"" Mesh System (K031961), Inion OTPS™ Mini Screws (K043142) and Inion OTPS™ Fixation System (K030900). The devices have passed the tests for functionality and handling in simulated clinical use settings and compare favourably to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2013
Inion Oy % Ms. Kati Marttinen Quality and Regulatory Director Lääkärinkatu 2 335200 Tampere Finland
Re: K123672
Trade/Device Name: Inion FreedomScrewTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 23, 2012 Received: November 29, 2012
Dear Ms. Marttinen:
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
3
Page 2 - Ms. Kati Marttinen
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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,
Erin I.D.Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number:
K123672 (pg 1/1)
Device Name:
Inion FreedomScrew™M
The Inion FreedomScrew™ products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
In addition, the Inion FreedomScrew™ Ø3.5/4.0/4.5 mm products are specifically intended for use in following indications:
A. General indications: maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.
B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.
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)
の日本の出版が出来ないというとして、そして、そして、日本の間に出来ている。 1981年には、 1981年には、 1992年には、 1972年(昭和47年)、 1972年(昭和47年) 1972年) 1972年(昭和47年) 1982年(昭和47年) 1982年(昭和47年) 1982年(昭和47年) 1982年(昭和47年)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ElizabethLMFrank-S
Divison of Orthopedic Devices