(3 days)
Not Found
No
The summary describes bioabsorbable screws for surgical fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is described as screws intended for use in trauma and reconstructive procedures of the craniofacial skeleton, midface, maxilla, and mandible, such as fixing fractures and assisting in osteotomies. These are surgical fixation devices, not therapeutic devices that treat a disease or condition with something like energy, radiation, or medication.
No
Explanation: The device, the Inion CPS™ 2.5/2.8 Screws, is described as being used for reconstructive and trauma procedures for fixing fractures and performing osteotomies. This indicates it is a surgical implant used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a physical screw made of PLDLA/TMC, intended for surgical implantation. This is a hardware device, 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 description and intended use clearly state that the Inion CPS™ 2.5/2.8 Screws are implants used for fixing bones in the craniofacial skeleton during surgical procedures. They are physically placed within the body.
Therefore, this device falls under the category of surgical implants or fixation devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Inion CPS" 2.5/2.8 Screws are intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) as a part of the Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System.
a) Fractures of the cranium, midface, maxilla and mandible.
b) Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations).
- c) LeFort (I, II, III) osteotomies.
d) Pediatric reconstructive procedures.
e) Orthognathic or reconstructive procedures of the cranium, midface, maxilla or mandible.
f) Craniotomy flap fixation.
The Inion CPS " Screws are not intended for use in and is contraindicated for: Mandibular tumor resection: 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). The system is not intended for use in the mandible without appropriate maxillomandibular fixation.
Product codes (comma separated list FDA assigned to the subject device)
JEY, HWC
Device Description
The Inion CPS" 2.5/2.8 Screw is provided with diameters of 2.5 mm and 2.8 mm. Length of the screw is 6 to 23 mm. The Inion CPS™ 2.5/2.8 Screws are made of PLDLA/TMC, same basic material as with predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton, midface, maxilla, mandible, cranium
Indicated Patient Age Range
Infant, Pediatric
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows a logo for a company called "UNION Intelligent Solution". The word "UNION" is in large, bold, white letters, with the "U" partially obscured by a white blotch. Below "UNION", the words "Intelligent Solution" are written in a smaller, white font. The background of the image is black.
SEP 1 2 2002
510(k) SUMMARY For the Inion CPS™ 2.5/2.8 Screw September/6/2002
ADMINISTRATIVE INFORMATION
Manufacturer´s Name:
Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere
Contact Person: Hanna Marttila Regulatory Affairs Manager Lääkärinkatu 2 FIN-33520 Tampere Phone: +358 3 230 6600 Fax: +358 3 230 6601
DEVICE NAME
Classification Name: Screw, Fixation, Bone Common/Usual Name: bone fixation fastener Trade Name: Inion CPS™ 2.5/2.8 Screw
ESTABLISHMENT REGISTRATION NUMBER
9710629
DEVICE CLASSIFICATION AND PRODUCT CODE
As shown in 21 CFR 888.3040 screws are classified as Class II. Screws have been assigned Product Code HWC.
PREDICATE DEVICE
(1) Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System (K010352)
1
INTENDED USE
The Inion CPS" 2.5/2.8 Screws are intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) as a part of the Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System.
a) Fractures of the cranium, midface, maxilla and mandible.
b) Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations).
- c) LeFort (I, II, III) osteotomies.
d) Pediatric reconstructive procedures.
e) Orthognathic or reconstructive procedures of the cranium, midface, maxilla or mandible.
f) Craniotomy flap fixation.
The Inion CPS " Screws are not intended for use in and is contraindicated for: Mandibular tumor resection: 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). The system is not intended for use in the mandible without appropriate maxillomandibular fixation.
DEVICE DESCRIPTION
The Inion CPS" 2.5/2.8 Screw is provided with diameters of 2.5 mm and 2.8 mm. Length of the screw is 6 to 23 mm. The Inion CPS™ 2.5/2.8 Screws are made of PLDLA/TMC, same basic material as with predicate device.
EQUIVALENCE TO MARKETED PRODUCTS
The Inion CPS™ 2.5/2.8 Screws are a modification to currently marketed Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System. Inion CPS™ 2.5/2.8 Screws have the same technological characteristics and it is offered with the same packaging and sterility options as with the Inion CPS™ System identified above. New feature is a minor change in material composition specifically in copolymer ratio. The Inion CPS™ 2.5/2.8 Screws have the same intended use and principles of operation as Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System and there is no change in safety or efficacy.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing strokes, facing left. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2002
Ms. Hanna Marttila Regulatory Affairs Manager Inion Limited Laakarinkatu 2 FN-33520 Tampere FINLAND
Re: K022981
Trade/Device Name: Inion CPS™ 2.5/2.8 Screw Regulation Number: 872.4760 and 888.3040 Regulation Name: Bone Plate and Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: JEY and HWC Dated: September 6, 2002 Received: September 9, 2002
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.
3
Page 2 - Ms. Marttila
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, 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). 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.
Atteuce Cuesito/for
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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 CPS ™ 2.5/2.8 Screw
Indications For Use:
Indications:
- A. General indications: The Inion CPS™ 2.5/2.8 Screws are intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) as a part of the Inion CPSTM 1.5/2.0/2.5 Bioabsorbable Fixation System.
- B. Specific indications:
- Fractures of the cranium, midface, maxilla and mandible.
- Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations).
- LeFort (I, II, III) osteotomies. .
- Pediatric reconstructive procedures.
- Orthognathic or reconstructive procedures of the cranium, midface, ● maxilla or mandible.
- Craniotomy flap fixation.
Contraindications:
The Inion CPS™ Screws are not intended for use in and is contraindicated for:
-
- Mandibular tumor resection
-
- 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)
-
- DO NOT USE in the mandible without appropriate maxillomandibular fixation.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Susan Ross
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device
Special 510(k)
510(k) Number ._
Date: 6.9.2002 Final