(95 days)
No
The device description and performance summary focus on the material properties and mechanical function of biodegradable screws for bone fixation. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device, Inion OTPS™ BIODEGRADABLE FIXATION SYSTEM, is a resorbable screw used for the mechanical fixation of bone fractures and grafts. It provides physical support rather than delivering a specific therapy or treatment.
No
The device is described as an implantable fixation system for bone fractures, osteotomies, arthrodeses, or bone grafts, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description clearly states it is a physical screw made of resorbable material intended for bone fixation, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts". This is a therapeutic and structural function within the body.
- Device Description: The description details a physical implant (screws) made of resorbable material, designed to provide mechanical support to 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a physical implant.
N/A
Intended Use / Indications for Use
These INION OTPSTM BIODEGRADABLE FIXATION SYSTEM implants are intended for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
Product codes
HWC
Device Description
Screws are generally intended for alignment and fixation of bone fractures, osteotomies, arthrodeses and bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast or brace). The Inion OTPS™ Screws are offered in several dimensions and lengths typical for this application.
The Inion OTPS™ Screws are made of resorbable poly (L-lactide-co-D,L-lactide) and poly (L-lactide-co-trimethylenecarbonate)]. The Inion OTPS™ Screw gradually loses its 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
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)
Based on the performance data presented in section I of this premarket notification it is stated that the Inion OTPS™ Screws are substantially equivalent to similar marketed devices, such as the ReUnite Screw 2.0/2.5 (K992301) and Linvatec SmartScrew (K003077).
The data demonstrates, that
-
Inion OTPS™ Screws retain sufficient mechanical characteristics to fulfil their intended function during bone healing according to their indications, and
-
the material and degradation by-products of the Inion OTPS™ Screws are biocompatible, with no short- or long-term safety concerns. Furthermore, there are no new risks associated with use of the Inion OTPS™ Screws as compared to the predicate biodegradable implants listed above.
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
K043142 pg. 172
FEB 1 8 2005
Image /page/0/Picture/2 description: The image shows the word "INION" in large, bold, white letters against a black background. Below the word "INION" is the phrase "Intelligent Solution" in a smaller, italicized font, also in white. The overall design is simple and clean, with a focus on the company name and its tagline.
510(k) SUMMARY
for the Inion OTPS™ 2.5/2.8/3.1 Biodegradable Screws
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 601 Hanna. Marttila@Inion.fi
DEVICE NAME
Trade name: Inion OTPS™ Biodegradable Mini Plating System Common/Usual Name: Screw Classification Name: Fixation Fastener
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 (Screw)
PREDICATE DEVICES
Biomet Inc.; ReUnite Bone Screw (K992301) Linvatec Smart Screw (K003077)
Inion OTPS Screws extension
Date: Nov 12,2004 Status: Final
1
Page of 2
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
Screws are generally intended for alignment and fixation of bone The Inion OTPS™ fractures, osteotomies, arthrodeses and bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast or prosence or appropriate fered in several dimensions and lengths typical for this application.
The Inion OTPS™ Screws are made of resorbable polylactic acid / trimethylenecarbonate The Imon OTI & - Leactide-co-D,L-lactide) and poly (L-lactide-co-trimethylenecarbonate)]. The Inion OTPS™ Screw 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
Based on the performance data presented in section I of this premarket notification it is stated Dasod on the perfectionery are substantially equivalent to similar marketed devices, such as that the ReUnite Screw 2.0/2.5 (K992301) and Linvatec SmartScrew (K003077).
The data demonstrates, that
-
Inion OTPS™ Screws retain sufficient mechanical characteristics to fulfil their intended function during bone healing according to their indications, and
-
the material and degradation by-products of the Inion OTPS™ Screws are biocompatible, with no short- or long-term safety concerns. Furthermore, there are no new risks associated with use of the Inion OTPS™ Screws as compared to the predicate biodegradable implants listed above.
Inion OTPS™ Screws are substantially equivalent to predicate Class II devices used for alignment and fixation of fractures, osteotomies, arthrodeses and bone grafts (i.e., autografts anginnents) in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast or brace), because the differences between the Inion OTPS™ Screws and these predicate devices do not raise new questions of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a human figure.
Public Health Service
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Hanna Marttila Director, Regulatory Affairs Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere, Finland
Re: K043142
:
Trade/Device Name: Inion OTPSTM 2.5/2.8/3.1 Screws Inion OTPS™ Biodegradable Mini Plating System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 1, 2005 Received: February 3, 2005
Dear Ms. Marttila:
We have reviewed your Section 510(k) premarket notification of intent to market the device w for hove and have 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 arior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that provision in the provision 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. Marttila
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and in yourse organizatial equivalence of your device to a legally premaince notification: "Thesalts 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 ir you at the Office of Compliance at (240) 276-0120. 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 general miormation on Journational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html
Sincerely yours,
Mark A. 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
Indications for Use
510(k) Number (if known): K043142
Inion OTPS™ 2.5/2.8/3.1 Screws Device Name:
Inion OTPS™ Biodegradable Mini Plating System
INDICATIONS:
These INION OTPSTM BIODEGRADABLE FIXATION SYSTEM implants are intended for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
CONTRAINDICATIONS:
These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM implants are not intended for use in and are contraindicated for:
- High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in . conjunction with traditional rigid fixation.
- . Spine indications.
- I Active or potential infection.
- Patient conditions including limited blood supply, insufficient quantity of bone; . and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse).
Prescription Use 2 4 (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marti A. Melleen
(Division Sign-OLL)
Division of General, Restorative,
and Neurological Devices
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510(k) Number K043142