(87 days)
Not Found
No
The summary describes a biodegradable pin for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for the maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses, or bone grafts, which directly addresses a disease or condition (bone issues) by providing structural support and facilitating healing.
No
The device is an implantable pin used for fixing bone fractures and grafts. It provides structural support rather than diagnosing conditions.
No
The device description clearly states it is a biodegradable pin made of resorbable copolymers, which is a physical implant, not software.
Based on the provided text, the Inion OTPS™ Biodegradable Pin is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses, or bone grafts. This is a surgical implant used directly in the body.
- Device Description: The description details a biodegradable pin made of specific polymers, designed to be implanted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is an implant used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
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).
Contraindications: The Inion OTPS™ Biodegradable Pin should not be used in fractures and osteotomies of diaphyseal bone or in cases with insufficient quality or quantity of bone. Other contraindications are active or potential infections, patient conditions including limited blood supply, and where patient cooperation cannot be guaranteed (e.g. alcoholism, drug abuse).
Product codes
HTY, HWC
Device Description
The Inion OTPS™ 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). Pins are offered in several dimensions and lengths typical for this application.
The Inion OTPS™ Biodegradable Pin is made of resorbable polylactic acid / trimethylenecarbonate copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. Pins are offered both undyed and coloured for better visualization during surgical operation. The Inion OTPS™ Biodegradable Pin gradually loses its strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.
The Inion OTPS™ Biodegradable Pin is substantially equivalent to those of the previously accepted and clinically successfully used biodegradable pins intended for similar indications. Inion OTPS™ Biodegradable Pin, SmartPin (K010983), OrthoSorb Absorbable Pin (K901456) and Polypin (K961608) have the same 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 Pin and predicate devices do not raise any new questions of safety and effectiveness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
AUG 2 8 2003
(03/7/2
Image /page/0/Picture/1 description: The image shows a logo for INION Intelligent Solution. The logo is white text on a black background. The word "INION" is in large, bold letters, and the words "Intelligent Solution" are in smaller letters below it. There is a white line on the left side of the image.
510(k) SUMMARY for the Inion OTPS™ Biodegradable Pin
MANUFACTURER Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere
Contact Person: Har.na 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 Pin Common/Usual Name: Pin, Fixation
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
Bionx Implants, Inc .; PLLA Pin (K010983) DePuy ACE; OrthoSorb Absorbable Pin (K901456) Synthes; Polypin (K961608)
Date: 20.5.2003 Status: Final
Pin
1
page 2 of 2
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The Inion OTPS™ 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). Pins are offered in several dimensions and lengths typical for this application.
The Inion OTPS™ Biodegradable Pin is made of resorbable polylactic acid / trimethylenecarbonate copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. Pins are offered both undyed and coloured for better visualization during surgical operation. The Inion OTPS™ Biodegradable Pin gradually loses its 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 Pin is substantially equivalent to those of the previously accepted and clinically successfully used biodegradable pins intended for similar indications.
Inion OTPS™ Biodegradable Pin, SmartPin (K010983), OrthoSorb Absorbable Pin (K901456) and Polypin (K961608) have the same 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 Pin and predicate devices do not raise any new questions of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird.
Public Health Service
AUG 2 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Hanna Marttila Regulatory Affairs Manager Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere Finland
Re: K031712
Trade/Device Name: Inion OTPS™ Biodegradable Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: May 20, 2003 Received: June 10, 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 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
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,
Sincerely yours,
Mark M. Milken
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
INION LTD.
510(k)
K 03/7/2
8
D STATEMENT OF INDICATIONS FOR USE
Applicant: Inion Ltd. 510(k) Number: Device Name: Inion OTPS™ Biodegradable Pin
Indications:
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).
Contraindications:
The Inion OTPS™ Biodegradable Pin should not be used in fractures and osteotomies of diaphyseal bone or in cases with insufficient quality or quantity of bone. Other contraindications are active or potential infections, patient conditions including limited blood supply, and where patient cooperation cannot be guaranteed (e.g. alcoholism, drug abuse).
| Prescription use | |
|---|---|
| Over the Counter use | No |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K031712 |
|---|---|
| Pin | |
| Date: 20.5.20 |
te: 20.5.2003 Status: Final