(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.
§ 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.