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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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