(25 days)
No
The 510(k) summary describes a bioabsorbable plate made of a specific copolymer for surgical fixation. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The device description focuses solely on the material and physical form of the plate.
No
The device is a bioabsorbable fixation plate used for traumatic and reconstructive procedures of the craniofacial skeleton, not for therapy to treat a disease or condition.
No
Explanation: The device is an orthognathic plate used for fixation in trauma and reconstructive procedures of the craniofacial skeleton, not for diagnosing medical conditions.
No
The device description explicitly states it is a physical plate made of resorbable polylactic acid/trimethylenecarbonate copolymer, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes the Inion CPS™ 2.0 Orthognathic Plate as a surgical implant used for fixing bones in the craniofacial skeleton. Its intended uses are for trauma, reconstructive procedures, and osteotomies.
- No Mention of Biological Samples or Testing: The description and intended use do not involve the analysis of any biological samples from the patient. The device is physically implanted into the body.
Therefore, based on the provided information, the Inion CPS™ 2.0 Orthognathic Plate is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Inion CPS" Orthognathic Plate is 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™ 2.0 Orthognathic Plate is 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
76 JEY
Device Description
The Inion CPS" 2.0 Orthognathic Plates are provided in different shapes similar to predicate device. The Inion CPS™ 2.0 Orthognathic Plate is made of resorbable polylactic acid/trimethylenecarbonate copolymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton, midface, maxilla and mandible
Indicated Patient Age Range
Adult, Pediatric, Infant
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
E
September/7/2001
Special 510(k) Summary for the Inion CPS™ 2.0 Orthognathic Plate
ADMINISTRATIVE INFORMATION
Manufacturer´s Name:
Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere
Contact Person: Hanna Marttila Regulatory Affairs Coordinator Lääkärinkatu 2 FIN-33520 Tampere Phone: +358 3 230 6600 +358 3 230 6601 Fax: -
DEVICE NAME
Classification Name: Common/Usual Name: Trade Name:
Bone Plate Bone Plating System Inion CPSTM 2.0 Orthognathic Plate
ESTABLISHMENT REGISTRATION NUMBER
Inion Ltd. has not yet obtained an Establishment Registration Number.
DEVICE CLASSIFICATION AND PRODUCT CODE
As shown in 21 CFR 872.4760 bone plates are classified as Class II. Bone Plates have been assigned Product Code 76 JEY.
PREDICATE DEVICES
(1) Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System (K010352)
1
INTENDED USE
The Inion CPS" Orthognathic Plate is 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™ 2.0 Orthognathic Plate is 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" 2.0 Orthognathic Plates are provided in different shapes similar to predicate device. The Inion CPS™ 2.0 Orthognathic Plate is made of resorbable polylactic acid/trimethylenecarbonate copolymer.
EQUIVALENCE TO MARKETED PRODUCTS
The Inion CPS™ Orthognathic Plate is a line extension to currently marketed Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System. Inion CPS™ 2.0 Orthognathic Plate has the same technological characteristics as the Inion CPS™ System identified above. Both will be offered in the same materials and with the same packaging and sterility options. Both the plates have the same intended use and principles of operation 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 Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
OCT - 5 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Hanna Marttila Regulatory Affairs Inion Limited Laakarinkatu 2 Tampere, FINLAND
Re: K013039
Trade/Device Name: Inion CPS 2.0 Orthognathic Plate Regulation Number: 872.4760 Regulation Name: Bone Plating System Regulatory Class: II Product Code: JEY Dated: September 7, 2001 Received: September 10, 2001
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
3
Page 2 - Ms. Marttila
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.
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) 594-4613 . 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,
Susan Kunner
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE D
Applicant: Inion Ltd. 510(k) Number: Device Name: Inion CPS ™ 2.0 Orthognathic Plate
Indications For Use:
Indications:
- A. General indications: The Inion CPS™ 2.0 Orthognathic Plate is 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.
- 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™ 2.0 Orthognathic Plate is 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 Runne
(Division Sian-Off Division of Dental, Infection Co and General Hospita 510(k) Number
Special 510(k)