(29 days)
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No
The document describes a biodegradable fixation system made of resorbable polymers and focuses on its material properties, degradation profile, and mechanical properties, with no mention of AI or ML.
Yes
The device is described as a "Biodegradable Fixation System" intended for the "maintenance of reduction of cancellous bone fractures, osteotomies or arthrodeses." These are medical conditions that the device aims to treat or stabilize, fitting the definition of a therapeutic device.
No
The device is a biodegradable fixation system intended for the maintenance of reduction of bone fractures, osteotomies, or arthrodeses, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "Biodegradable Fixation System implants" made of "resorbable polylactic acid / trimethylenecarbonate copolymers," indicating it is a physical implant, not software.
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 for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a biodegradable fixation system intended for the surgical repair of bone fractures and osteotomies. These are implants placed within the body to stabilize bone.
- Intended Use: The intended use clearly states the system is for "maintenance of reduction of cancellous bone fractures, osteotomies or arthrodeses." This is a surgical procedure, not a diagnostic test performed on a specimen.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
A. General indications: These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM issuplants are generally intended for 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 ●
- . Ankle fractures
Product codes
HWC
Device Description
The modified Inion OTPS™ Biodegradable Fixation system implants are identical to the currently cleared devices except for the modifications which have been detailed in section 3 of this submission.
Inion OTPS™ Biodegradable Fixation System implants are made of resorbable polylactic acid / trimethylenecarbonate copolymers. Inion O'EPS™ Biodegradable Fixation System implants gradually lose their strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
upper extremity, ankle and foot
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows a logo with the word "MOON" in large, bold, white letters. Below the word "MOON" is the phrase "Intelligent Solution" in a smaller, italicized font. The background is split vertically, with the left side appearing lighter and textured, while the right side is darker and more solid.
SPECIAL 510(k) SUMMARY for the modification to Inion OTPS™ Biodegradable Fixation Systern (K030900)
OCT = 4 2006
MANUFACTURER
Inion Oy, Lääkärinkatu 2, FIN-33520 Tampere, FINLAND
Contact Person
Kati Marttinen, Regulatory Affairs Specialist Lääkärinkatu 2, FIN-33520 Tampere Phone: +358 3 2306 600 Fax: +358 3 2306 691 kati.marttinen@inion.com
DEVICE NAME
Trade name: Inion OTPS™ Biodegradable Fixation System Common/Usual Name: Biodegradable bone screw Classification Name: bone fixation screw
ESTABLISHMENT REGISTRATION NUMBER
9710629
DEVICE CLASSIFICATION AND PRODUCT CODE
Classification panel: Orthopedic Regulation number: 21 CFR 888,3040 Regulation name: Smooth or threaded metallic 'sone fixation fastener Regulatory Class: Class II Product Code: HWC
PREDICATE DEVICE
Inion OTPS™ Biodegradable Fixation System (K030900)
CONFORMANCE WITH PERFORMANCE STANDARDS
No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application.
1
Image /page/1/Picture/1 description: The image shows a logo with the letters "ON" in a bold, sans-serif font. Below the letters, there is the text "Intelligent Solution" in a smaller, lighter font. The background is a mix of black and white, with a grainy texture that gives the image a slightly distressed look. The logo and text are white, contrasting with the darker background.
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The modified Inion OTPS™ Biodegradable Fixation system implants are identical to the currently cleared devices except for the modifications which have been detailed in section 3 of this submission.
Inion OTPS™ Biodegradable Fixation System implants are made of resorbable polylactic acid / trimethylenecarbonate copolymers. Inion O'EPS™ Biodegradable Fixation System implants gradually lose their strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.
Indications
Inion OTPS™ Biodegradable Fixation system screws are generally intended for 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. Specific indications:
- Fractures and osteotomies of the malleoli ເ
- Ankle fractures
EQUIVALENCE TO MARKETED PRODUCTS
Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and mechanical properties of the modified Inion OTPS™ Biodegradable Fixation system screws are substantially equivalent with the predicate device Inion OTPSTM Biodegradable Fixation system (K030900).
The modified Inion OTPS™ Biodegradable Fixation system screws are substantially equivalent to predicate Class II devices used for 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, because the differences between the modified Inion OTPSTM Biodegradable Fixation system screws and the predicate device do not raise new questions of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming the wings and a snake winding around a staff.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT = 4 2006
Inion Ltd c/o Ms. Kati Marttinen Regulatory Affairs Specialist Lääkärinkatu 2. FIN-33520 Tampere, Finland
Re: K062617
Trade/Device Name: Inion OTPS™ Biodegradable Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 31, 2006 Received: September 5, 2006
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 -- Ms. Kati Marttinen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance artits toll=free™ator (2007-638-2011 cr 240-276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours.
Sincerely, yours,
Jubara mucttr
Mark N. Melkerson 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: K062617
Device Name: Inion OTPS™ Biodegradable Fixation System
Indications:
A. General indications: These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM issuplants are generally intended for 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 ●
- . Ankle fractures
Contraindications:
These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM implants are not intended for use in and are contraindicated for:
· Active or potential infection.
· Patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse).
· High-load bearing applications.
Prescription Use Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE:-CONTINUE ON ANOTHER PAGE OF NEEDEL)
Concurrence of CDRH, Office of Device Evaluation (ODE)
chabara buchn
(Division Sign-Of Division of General, Restorative, and is curological Devices
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510(k) Number K062617