(441 days)
Not Found
No
The 510(k) summary describes a biodegradable screw for meniscus repair and does not mention any AI or ML components or functionalities.
Yes
The device is described as "intended for use in the fixation of longitudinal vertical meniscus lesions" which means it is used to treat a medical condition.
No
The device is a biodegradable screw used for the fixation of meniscus lesions, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical, implantable screw made of biodegradable materials, intended for surgical fixation. It also mentions customized instrumentation. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This is done outside of the body (in vitro).
- Device Description: The Inion Trinion™ Biodegradable Meniscus Screw is a surgical implant used to fix a torn meniscus within the body. It is a physical device used for repair, not for testing or analyzing biological samples.
- Intended Use: The intended use is for the "fixation of longitudinal vertical meniscus lesions," which is a surgical procedure.
Therefore, based on the provided information, the Inion Trinion™ Biodegradable Meniscus Screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Inion Trinion™ Biodegradable Meniscus Screw is indicated for use in the fixation of longitudinal vertical meniscus lesions (bucket handle) located in the vascularized area of the meniscus (red-red and red-white areas).
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
The Inion Trinion™ Biodegradable Meniscus Screw is intended for use in the fixation of I he Infon Trinon - Diodcepadable Monised - Decated in the vascularized area of the longhudmal vertion membeds renoms ( Screws are offered in different lengths typical for this application. The system will be provided sterile to the user and is not to be re-sterilized. this upplication. " The oyengiscus Screw is designed to be used with customized instrumentation.
The Inion Trinion™ Biodegradable Screw is made of resorbable polylactic acid / trimethylenecarbonate copoylmers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. The Inion Trinion™ Biodegradable Meniscus Screws are offered both undyed and coloured for better visualization during surgical operation. The Trinion™ Biodegradable Meniscus Screw gradually looses its strength during 18-36 weeks. Bioresorption takes place within two to three years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
meniscus
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)
Biomechanical testing demonstrates that the device is substantially equivalent to the predicate ones.
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.
K980681, K002020, K991715, K955768
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
AUG 1 6 2004
Image /page/0/Picture/1 description: The image shows handwritten text that appears to be a combination of letters and numbers. The text reads "Ko31714" followed by "F". The writing style is cursive, and the text is written in black ink on a white background.
Image /page/0/Picture/2 description: The image is a logo for INION, which is written in large, bold, white letters against a black background. Below the word INION, in a smaller font size, is the phrase "Intelligent Solution", also in white. The overall design is simple and modern, emphasizing the company's name and its focus on providing smart solutions.
510(k) SUMMARY for the Inion Trinion™ Biodegradable Meniscus Screw
MANUFACTURER Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere
Contact Person: Hanna Marttila Regulatory Affairs Manager Lääkärinkatu 2 FIN-33520 Tampere Phone: +358 3 2306 600 Fax:+358 3 2306 601 Hanna. Marttila@Inion. fi
DEVICE NAME
Trade name: Inion Trinion™ Biodegradable Meniscus Screw Common/Usual Name: Biodegradable Meniscal Screw
ESTABLISHMENT REGISTRATION NUMBER 9710629
DEVICE CLASSIFICATION AND PRODUCT CODE
Classification panel: Orthopedic Regulatory Class: Class II, MAI
PREDICATE DEVICES
Innovasive Devices, Inc.; Innovasive Meniscal Screw (K980681) Mitek Clearfix Biomet, Inc .; LactoSorb Meniscal Screw (K002020) Linvatec Corp .; BioStinger -V Bioabsorbable Meniscal Repair Device (K991715) Bioscience, Inc.; Biofix Biodegradable Meniscus Arrow System (K955768)
Date: 15.5.2003 Status: Final
1
K031714 pge \frac{2}{2}
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The Inion Trinion™ Biodegradable Meniscus Screw is intended for use in the fixation of I he Infon Trinon - Diodcepadable Monised - Decated in the vascularized area of the longhudmal vertion membeds renoms ( Screws are offered in different lengths typical for this application. The system will be provided sterile to the user and is not to be re-sterilized. this upplication. " The oyengiscus Screw is designed to be used with customized instrumentation.
The Inion Trinion™ Biodegradable Screw is made of resorbable polylactic acid / trimethylenecarbonate copoylmers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. The Inion Trinion™ Biodegradable Meniscus Screws are offered both undyed and coloured for better visualization during surgical operation. The Trinion™ Biodegradable Meniscus Screw gradually looses its strength during 18-36 weeks. Bioresorption takes place within two to three years.
EQUIVALENCE TO MARKETED PRODUCTS
The properties of the Inion Trinion™ Biodegradable Meniscus Screw are substantially equivalent to those of the previously accepted and clinically successfully used biodegradable meniscal repair devices.
Inion Trinion™ Biodegradable Meniscus Screw, Innovasive Meniscal Screw (Mitek Clearfix), LactoSorb Meniscal Screw, BioStinger -V Bioabsorbable Meniscal Repair Device and Biofix Biodegradable Meniscus Arrow System have the same intended use and principles of operation and very similar design characteristics. Biomechanical testing demonstrates that the device is substantially equivalent to the predicate ones. Differences between The Inion Trinion™ Biodegradable Meniscus Screw and predicate devices do not raise new questions of safety and effectiveness.
Date: 15.5.2003 Status: Final
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2004
Ms. Hanna Marttila Regulatory Affairs Manager Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere Finland
Re: K031714
R031714
Trade/Device Name: Inion Trinion™ Biodegradable Meniscus Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 27, 2004 Received: June 1, 2004
Dear Ms. Marttila:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to regars) to regars the Medical Device Americal processed on the connineres phor to may 20, 1978) in accordance with the provisions of the Federal Food, Drug, de rices that have been recises in at require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercrore, manel and not include requirements for annual registration, listing of general controls proficions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is clusioned (600 a00 ro) als. Existing major regulations affecting your device can may be subject to satil additions, 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 Flease be advised that I Dris issualite or our device complies with other requirements of the Act that I Dri has made a actionments in administered by other Federal agencies. You must of any I catal states and equirements, including, but not limited to: registration and listing (21 Comply with an the Hot of equaliements, and manufacturing practice requirements as set CFN i at 607), adoling (21 OFF Part 820), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Hanna Marttilla
This letter will allow you to begin marketing your device as described in your device to 1 low I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification. The PDA midnig of substantial equive and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac (1) 594-4639. Also, please note the regulation entitled, a Colliact the Office of Compilance w (2 st notification" (21CFR Part 807.97) you may obtain. Misoraliding of telefone to premation on your responsibilities under the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milbern
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known).
Device Name: Inion Trinion™ Biodegradable Meniscus Screw
Indications:
The Inion Trinion™ Biodegradable Meniscus Screw is indicated for use in the fixation of longitudinal vertical meniscus lesions (bucket handle) located in the vascularized area of the meniscus (red-red and red-white areas).
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Millerson
(Division Sign-Off, Restorative, Division " " " " " " " " " and Neurological Devices
510(k) Number K031714
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