(28 days)
The Inion CPS™ BSSO Screw 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™ BSSO Screw 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.
The Inion CPS™ BSSO Screws are provided with diameters of 2.8 mm and 3.1 mm. Length of the screws ranges from 10 mm to 18 mm. The Inion CPS™ BSSO Screws are made of PLDLA/TMC, same material as with predicate device.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any such criteria. The document is a 510(k) summary for a medical device (Inion CPS™ BSSO Screw) and focuses on administrative information, device description, intended use, and its equivalence to a predicate device. It does not contain details regarding performance studies, sample sizes, expert involvement, or ground truth establishment.
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K020266 page 192 7
1 510(k) SUMMARY
For the Inion CPS™ BSSO Screw
FEB 2 2 2002
January/22/2002
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 Fax: +358 3 230 6601
DEVICE NAME
Classification Name: Screw, Fixation, Bone Common/Usual Name: bone fixation fastener Trade Name: Inion CPS™ BSSO Screw
ESTABLISHMENT REGISTRATION NUMBER
Inion Ltd. has not yet obtained an Establishment Registration Number.
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)
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INTENDED USE
The Inion CPS " BSSO Screw 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" BSSO Screw 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 " BSSO Screws are provided with diameters of 2.8 mm and 3.1 mm. Length of the screws ranges from 10 mm to 18 mm. The Inion CPS" BSSO Screws are made of PLDLA/TMC, same material as with predicate device.
EQUIVALENCE TO MARKETED PRODUCTS
The Inion CPS™ BSSO Screw is a line extension to currently marketed Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System. Inion CPS™ BSSO Screw has the same technological characteristics as the Inion CPS™ System identified above. They will be offered in very similar materials and with the same packaging and sterility options. The Inion CPS™ BSSO Screw has 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.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2002
Ms. Hanna Marttila Regulatory Affairs Coordinator Inion Ltd. Laakarinkatu 2 Fin-33520, Tampere Finland
Re: K020266
Trade/Device Name: CPS™ BSSO Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 22, 2002 Received: January 25, 2002
Dear Ms. Marttila:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becamed the device is substantially equivalent (for the indications felerenced above and nave acterially marketed predicate devices marketed in interstate for use stated in the encreate) to regard cate of the Medical Device Amendments, or to commerce proc to May 20, 2017 11:23 accordance with the provisions of the Federal Food, Drug, de vices that have over require approval of a premarket approval application (PMA). allu Cosmetic Act (Fiel) market the device, subject to the general controls provisions of the Act. The Tourmal controls provisions of the Act include requirements for annual registration, listing of general volurols provision 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 If your device is classified (600 a00 rols. Existing major regulations affecting your device can may be subject to sacer as acceptations, 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must of any I catales and 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 CI It Fatt 6077, accems (21 (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) This letter will anow you to ocg.il manisang your device of your device of your device to a legally premaired 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 If you desire specific advice to: Jour vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-4659. Traditionship, liance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). regulation entitled, "Misolanding of Telection of the Act may be obtained from the Other general information on your responsional 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,
Mark A. Millican
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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P STATEMENT OF INDICATIONS FOR USE
Applicant: Inion Ltd. 510(k) Number: Device Name: Inion CPS ™ BSSO Screw
Indications For Use:
Indications:
- A. General indications: The Inion CPS™ BSSO Screw is intended for use in trauma and Constructive 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™ BSSO Screw 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 I atrent bonuhere 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)
Mark N Miller
(Division Sign-Cif) Division of General, Restorative and Neurological Devices
510(k) Number -
Special 510(k)
§ 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.