(28 days)
The Inion OTPSTM Biodegradable Pin is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
The Inion OTPS™ Biodegradable Pin is indicated for maintenance of alignment and fixation The missi OFF . Breedomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
Previously 510(k) cleared Inion OTPS™ Biodegradable Pin (K031712) is manufactured by extrusion followed by grinding and cutting. With this special 510(k) we inform for additional manufacturing method by injection moulding followed by cutting. Injection moulded Inion OTPSTM Biodegradable Pins are identical in all the other aspects with the predicate pins except this manufacturing method. Material recipe with copolymer composition is identical. Only difference is that the molecular weight is slightly higher with the extrusion recipe than with the injection moulding recipe.
The provided text is a Special 510(k) Summary for a medical device called the "Inion OTPS™ Biodegradable Pin." This document describes a modification to the manufacturing method of an already cleared device, not the initial approval of a new device or its performance against acceptance criteria in a clinical study.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, specifically:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence of a modified manufacturing method (injection molding) to a previously cleared manufacturing method (extrusion). It states that the injection-molded pins are "essentially identical" and "substantially equivalent" to the predicate device, with "no new risks associated with use... as compared to the predicate device." This equivalence is "shown by the verification testing," but details of this testing (specific criteria, results, sample sizes, etc.) are not included in this summary.
The document's purpose is to inform the FDA that a manufacturing change does not alter the device's safety or effectiveness, allowing it to remain on the market. It's not a report of a new clinical or performance study establishing new acceptance criteria or proving their fulfillment.
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Image /page/0/Picture/1 description: The image is a logo for a company called "INION Intelligent Solution". The logo is black and white, with the word "INION" in large, bold letters. Below the word "INION" is the phrase "Intelligent Solution" in a smaller font. The logo is simple and modern, and it conveys the idea of intelligence and innovation.
MAR 7 - 2005
K050275 pge'1/2
SPECIAL 510(k) SUMMARY for the INION OTPS™ Biodegradable Pin / device modification
MANUFACTURER
Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere
Contact Person
Hanna Marttila Regulatory Affairs Director Lääkärinkatu 2 FIN-33520 Tampere Phone: +358 3 2306 600 Fax: +358 3 2306 691 Hanna.Marttila@Inion.fi
DEVICE NAME
Trade name: Inion OTPS™ Biodegradable Pin Common/Usual Name: Pin, Fixation
ESTABLISHMENT REGISTRATION NUMBER 9710629
DEVICE CLASSIFICATION AND PRODUCT CODE
Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY
PREDICATE DEVICE
Inion OTPS™ Biodegradable Pin (K031712)
CONFORMANCE WITH PERFORMANCE STANDARDS
No applicable mandatory performance standards exist for this device.
THE REASON FOR Special 510(k)
Currently the Inion OTPSTM Biodegradable Pins are manufactured by extrusion followed by grinding and cutting. This special 510(k) is submitted to additional manufacturing method by injection moulding followed by cutting.
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Image /page/1/Picture/0 description: The image shows a logo with the word "INION" in bold, white letters against a black background. Below the word "INION" is the phrase "Intelligent Solution" in a smaller, white font. The logo appears to be for a company or product, with the phrase "Intelligent Solution" suggesting a focus on technology or problem-solving. There is a vertical line going through the middle of the image.
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page, #2
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The Inion OTPS™ Biodegradable Pin is indicated for maintenance of alignment and fixation The missi OFF . Breedomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
Previously 510(k) cleared Inion OTPS™ Biodegradable Pin (K031712) is manufactured by extrusion followed by grinding and cutting. With this special 510(k) we inform for additional manufacturing method by injection moulding followed by cutting. Injection moulded Inion OTPSTM Biodegradable Pins are identical in all the other aspects with the predicate pins except this manufacturing method. Material recipe with copolymer composition is identical. Only difference is that the molecular weight is slightly higher with the extrusion recipe than with the injection moulding recipe.
EQUIVALENCE TO MARKETED PRODUCTS
Injection moulded Inion OTPS™ Biodegradable Pins are essentially identical with the previously 510(k) cleared extruded/machined Pins. Raw material composition with the both devices is identical except slightly lower molecular weight with the injection moulding recipe when compared to the extrusion/machining recipe. Degradation by-products are biocompatible, with no short - or long-term safety concerns. There are no new risks associated with use of the injection moulded Inion OTPS™ Biodegradable Pins as compared to the predicate device.
Injection moulded Inion OTPS™ Biodegradable Pins are substantially equivalent to predicate device used in maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts as shown by the verification testing and do not raise any new questions on safety and effectiveness.
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Image /page/2/Picture/1 description: The image is a circular seal with the logo of the U.S. Department of Health and Human Services. The seal features the department's emblem, which is a stylized caduceus-like symbol with three lines forming a human figure, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 7 - 2005
Ms. Hanna Marttila Director, Regulatory Affairs Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere Finland
Re: K050275
Trade/Device Name: Inion OTPSTM Biodegradable Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: February 3, 2005 Received: February 7, 2005
Dear Ms. Marttila:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your bector. 9 re(x) presidentially equivalent (for the indications ferenced above and nave actering gally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to comments proc to May 20, 1976, the encordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require subject to the general controls provisions of the Act. The r ou may, merciole, market the act include requirements for annual registration, listing of general controls provisions of the fies 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 classified (500 a0070) ins Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controller Lines gold to 898. In addition, FDA may be found in the Out of Peachasing
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 I lease be advised that 11971 3185aanse or our device complies with other requirements of the Act that ITA has made a determinations administered by other Federal agencies. You must of ally Federal statutes und regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set a CTN in the quality systems (Dr CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Ms. Hanna Marttila
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin maneting your antial equivalence of your device to a legally premarket nother 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 If you desire specific advice for your ac not the other note the regulation entitled, the most obtain contact the Office of Compliance at (210) 276 - 31257 Part 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. " Misbranding by Telefone to premation in the Act may be obtained from 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/industry/support/index.html
Sincerely yours,
Mark A. Mulkerson
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Applicant: Inion Ltd. 510(k) Number: Kolo > 7 ﺩ ﮐﺎ 7 ﺩ ﻣ ﮐﺎ Device Name: Inion OTPS™ Biodegradable Pin
The Inion OTPSTM Biodegradable Pin is indicated for maintenance of alignment and fixation I he mon OTPS … Blodegradable in is manental res grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
Contraindications:
The Inion OTPS™ Biodegradable Pin should not be used in fractures and osteotomies of The Inton OTTS - Droughted with insufficient quality or quantity of bone. Other diaplyson "oone" of " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " supply, and where patient cooperation cannot be guaranteed (e.g. alcoholism, drug abuse).
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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of __
§ 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.