(250 days)
The Inton OTPS™ Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue, e.g. bone grafts, bone graft substitutes, or bone fragments position of weak bony chsode, eightsm Biodegradable Mesh Plating System is also indicated for cement restriction in total joint arthroplasty procedures.
Only when used in conjunction with traditional rigid fixation, the Inion OTPSTM Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue in trauma and reconstructive orthopaedic procedures involving the following:
- Long bones
- Flat bones
- Short bones
- · Irregular bones
- · Appendicular skeleton
- Thorax
When used alone (without traditional rigid fixation), the Inion OTPS™ Biodegradable when used arone (without and to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopaedic procedures involving:
· Tumor resections where bone strength has not been compromised.
- · Iliac crest harvest sites.
The Inion OTPS™ Biodegradable Mesh Plating System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures.
The Inion OTPS™ Biodegradable Mesh Plating System is composed of various size mesh Internation associated fixations screws made of resorbable polylactic acid / pianes and associate a copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. The Inion OTPS™ Biodegradable Mesh Plating System implants armlually lose their strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.
This document describes the Inion OTPS™ Biodegradable Mesh Plating System. However, it does not contain any information regarding acceptance criteria, device performance, or any studies involving test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance of an AI algorithm.
The provided K031961 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on intended use, principles of operation, and mechanical testing. It does not include the type of performance study details requested in the prompt, which are typically associated with devices that involve diagnostic or predictive algorithms.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study to prove acceptance, as this information is not present in the provided text.
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K03196/ P42 '14
MAR - 1 2004
Image /page/0/Picture/2 description: The image shows a logo with the word "INION" in bold, white letters. Below "INION" is the phrase "ligent Solution" in a smaller, white font. The background is black, and there is a white circle to the left of the word "INION".
510(k) SUMMARY for the Inion OTPS™ Biodegradable Mesh Plating System
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 Harma. Marttila@ Inion. fi
DEVICE NAME
Trade name: Inion OTPS™ Biodegradable Mesh Plating System Classification Name: Bone, Plate
ESTABLISHMENT REGISTRATION NUMBER 9710629
DEVICE CLASSIFICATION AND PRODUCT CODE
Classification panel: Orthopedic Regulatory Class: Class II 21 CFR 888.3030, 87 HRS (plate)
PREDICATE DEVICES
(1) MacroPore OS Trauma System (K021164)
Date: 18.6.2003 Status: Final
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Kos 1961 page 72
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The Inion OTPS™ Biodegradable Mesh Plating System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures.
The Inion OTPS™ Biodegradable Mesh Plating System is composed of various size mesh Internation associated fixations screws made of resorbable polylactic acid / pianes and associate a copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. The Inion OTPS™ Biodegradable Mesh Plating System implants armlually 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™ Mesh Biodegradable Plating System is substantially equivalent to I in implants, indicated for the reinforcing of weak bony tissues in orthopaedic brodegradures and when used in conjunction with traditional rigid fixation., which have proodal 50 0(k) clearance, including MacroPoreOS Trauma System (K021164),
16ccroPoreOS Protective Sheet (K994158) and Synthes Resorbable Meshes and Sheets (KNO3788). These devices have the same intended use and principles of operation and very (1000700). Incol arrecteristics. Mechanical testing demonstrates that the device is substantially equivalent to the predicate ones. Differences between The Inion OTPS™ surstandary "Equirations on "The System and predicate devices do not raise any new questions of safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an abstract emblem resembling an eagle or bird-like figure with three horizontal lines above it, possibly representing feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2004
Ms. Hanna Marttila Regulatory Affairs Manager Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere Finland
Re: K031961
Trade/Device Name: Inion OTPS™ Biodegradable Mesh Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: December 2, 2003 Received: December 4, 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 rcclassified 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 complics 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 CHR 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.
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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 ins icter will anow you to ogin maing of substantial equivalence of your device to a legally premarket notineation: The Price 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 acrise for your as (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 Oinci general mionnation 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/cdrh/dsma/dsmamain.html
Sincercly yours,
Miriam C. Provost
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
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Indications for Use
510(k) Number (if known): K031961
Device Name: INION OTPS™ Biodegradable Mesh Plating System
Indications For Use:
The Inton OTPS™ Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue, e.g. bone grafts, bone graft substitutes, or bone fragments position of weak bony chsode, eightsm Biodegradable Mesh Plating System is also indicated for cement restriction in total joint arthroplasty procedures.
Only when used in conjunction with traditional rigid fixation, the Inion OTPSTM Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue in trauma and reconstructive orthopaedic procedures involving the following:
- Long bones
- Flat bones
- Short bones
- · Irregular bones
- · Appendicular skeleton
- Thorax
When used alone (without traditional rigid fixation), the Inion OTPS™ Biodegradable when used arone (without and to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopaedic procedures involving:
· Tumor resections where bone strength has not been compromised.
- · Iliac crest harvest sites.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use I (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)
Muriam C. Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of __
510(k) Number K03196/
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.