Search Results

The INION CPS™ BABY 1.5 BIOABSORBABLE FIXATION SYSTEM implants are intended for use in trauma and reconstructive procedures in the mid-face and maxilla of infant (from 29 days to 2 years of age) and child (greater than 2 years to 12 years of age) patients.

Specific indications:

• congenital anomalies correction in the orbital rim, orbital floor, maxilla and midface
• traumatic injuries.

The INION CPS™ 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM implants are intended for use in trauma and reconstructive procedures, and to maintain the relative position of bone grafts or bone graft substitutes, in orbital floor, medial and lateral orbital walls, orbital rim, mid-face, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) of child (greater than 2 years to 12 years of age), adolescent (greater than 12 years through 21 years of age) and adult patients. Specific indications: fixation of LeFort (I, II, III) osteotomies and mandibular orthognathic procedures

Inion CPS™ and Inion CPS™ Baby implants are bioabsorbable plates, screws and mesh plates made of bioabsorbable co-polymers. Inion CPS™ 1.5/2.0/2.5 System implants are composed of L-lactic acid, D-lactic acid and Trimethylenecarbonate. Inion CPS™ 1.5 Baby System implants are composed of L-lactic acid, D-lactic acid and Poly-Glygolic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption of Inion CPS™ implants takes place within 2-4 years, and Inion CPS™ Baby implants within 2-3 years.

The systems consist of fixation plates, meshes and screws offered in different sizes and designed to be used with the Inion CPS™ bone drill bits, bone taps, self-drilling bone taps, countersinks, screw drivers, plate bending pliers and heating device. Nonsterile instruments are intended to be cleaned and sterilized before initial use and after each use.

The implants are provided sterile by gamma irradiation. They are intended for single use and shall not be re-sterilized or re-used. Implants are non-pyrogenic and fully synthetic. The Subject Device is not intended for use in the orbital roof and can only be used if no exposure of the intracranial compartment is presented.

N/A

Ask a specific question about this device

The Synthes OrthoMesh Resorbable Graft Containment system is indicated for use in maintaining the relative position of weak bony tissue such as bone grafts, bone graft substitutes or bone fragments from comminuted fractures.

OrthoMesh implants may be used alone (without traditional rigid fixation) to maintain the relative position of bone grafts, bone graft substitutes or bone fragments in non-load-bearing reconstructive procedures involving areas where bone stability has not been compromised, such as tumor resections and iliac crest graft harvest sites.

OrthoMesh implants must be used in conjunction with traditional rigid fixation in load bearing applications to maintain the relative position of bone grafts, bone graft substitutes or bone fragments in reconstructive procedures involving long bones, flat bones, short bones, irregular bones, appendicular skeleton and thorax. These devices are not intended for use in the spine. The devices are not intended for load bearing indications unless used in conjunction with traditional rigid fixation

The Synthes OrthoMesh Resorbable Graft Containment System is comprised of meshes of 0.5mm, 0.8mm and 1.2mm thickness, and lengths and widths ranging from 48mm to 125mm. The Synthes OrthoMesh Resorbable Graft Containment System is also comprised of screws with a diameter ranging from 1.5mm to 2.5mm, and a length ranging from 4mm to 8mm. These implants are made from the resorbable copolymer poly (L-lactide-co-glycolide) that resorbs in vivo by hydrolysis into lactic and glycolic acids, and that are then metabolized by the body. Synthes OrthoMesh implants are resorbed completely within approximately 12 months. The implants are provided sterile and are intended for single patient use. OrthoMesh may be held in place with screws.

The provided text does not contain information about acceptance criteria or a study that proves a device meets those criteria.

The document is a 510(k) summary and an FDA clearance letter for the Synthes OrthoMesh Resorbable Graft Containment System. It describes the device, its intended use, contraindications, and declares its substantial equivalence to predicate devices. However, it does not include performance data, clinical study results, or specific acceptance criteria for device performance.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, data provenance, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.

Ask a specific question about this device