(87 days)
Not Given
No
The document describes a biodegradable fixation system made of specific polymers and focuses on its mechanical properties and resorption time. There is no mention of AI, ML, image processing, or any computational analysis of data.
No.
The device is described as a fixation system for bones, intended for reduction and fixation of fractures and osteotomies, rather than for treatment or therapy of a disease or condition.
No
The document describes a biodegradable fixation system designed for maintenance of reduction and fixation of bone fractures. Its intended use focuses on treatment and support, not on identifying or diagnosing a condition.
No
The device description clearly states it is a "Biodegradable Fixation System" made of resorbable copolymers, which are physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Inion OTPS Biodegradable Fixation System is described as a system for fixing bone fractures and osteotomies. It is implanted directly into the body to provide structural support.
- Lack of Mention of Samples or Testing: The description and intended use do not mention any testing of biological samples or providing diagnostic information.
Therefore, the Inion OTPS Biodegradable Fixation System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Inion OTPS Biodegradable Fixation System is 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 .
- Ankle fractures
Product codes
HWC
Device Description
The Inion OTPS™ Biodegradable Fixation System is 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.
The Inion OTPS™ Biodegradable Fixation System is made of resorbable polylactic acid / trimethylenecarbonate copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. The Inion OTPS™ 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremity, ankle and foot
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
Ko3o900 page 1 of 2
UNION
elligent Solution
510(k) SUMMARY for the Inion OTPS™ Biodegradable Fixation System
JUN 1 9 2003
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 OTPS™ Biodegradable Fixation System Classification Name: bone, fixation, screw
ESTABLISHMENT REGISTRATION NUMBER 9710629
DEVICE CLASSIFICATION AND PRODUCT CODE Classification panel: Orthopedic Regulatory Class: Class II 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener, 87-HWC
PREDICATE DEVICES
(1) Bionx Inc .; SmartScrew (K012001, K003077) (2) Biomet Bone Screw (K964970)
Date:20.3.2003 Status: Final
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Page 2 of 2
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The Inion OTPS™ Biodegradable Fixation System is 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.
The Inion OTPS™ Biodegradable Fixation System is made of resorbable polylactic acid / trimethylenecarbonate copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. The Inion OTPS™ 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.
EQUIVALENCE TO MARKETED PRODUCTS
The Inion OTPS™ Biodegradable Fixation System is substantially equivalent to biodegradable implants, intended for similar indications, which have received 510(k) clearance. Inion OTPS™ Biodegradable Fixation System implants, Bionx Inc. SmartScrew (K012001, K003077) and Biomet Bone Screw (K964970) have the same intended use and principles of operation and very similar design characteristics. Mechanical testing demonstrates that the device is substantially equivalent to the predicate ones. Differences between the Inion OTPS™ Biodegradable Fixation System and predicate devices do not raise any new questions of safety and effectiveness.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with lines suggesting movement or connection between them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2003
Ms. Hanna Marttila Regulatory Affairs Manager Inion Ltd. Lääkärinkatu 2 Fin-33520 Tampere Finland
Re: K030900
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: II Product Code: HWC Dated: March 19, 2003 Received: March 24, 2003
Dear Ms. Marttila:
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
3
Page 2 - Ms. Hanna Marttila
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. 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 (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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.
L. Mark N. Wilkerson
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
D STATEMENT OF INDICATIONS FOR USE
Applicant: Inion Ltd 510(k) Number: Device Name: Inion Biodegradable Fixation System
Indications:
The Inion OTPS Biodegradable Fixation System is 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 .
- Ankle fractures
Contraindications:
The OTPS Biodegradable Fixation System is not intended for use in and is 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) 3. High load bearing applications
Prescription use __ Over the Counter use
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
Mark A. Melkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K 030906 510(k) Number _
Date: 19.3.2003 Status: Final