(164 days)
Cross.Bone Blocks - CROSS.BONE BLOCK is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
— Filling losses of bone material resulting from a fracture.
— Filling losses of bone material after the resection of benign tumors or cysts
Cross.Bone Bottles - CROSS.BONE BOTTLE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
- Filling losses of bone material resulting from a fracture.
– Filling losses of bone material after the resection of benign tumors or cysts.
Cross.Bone Syringe - CROSS.BONE SYRINGE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
- Bone filler following a fracture,
- Bone filler following resection of benign tumors or cysts,
When the cavity to be filled is large, it is recommended to cover it with a resorbable membrane.
Cross.Bone Wedge - CROSS.BONE WEDGE is recommended for tibial osteotomy with internal fixation, and necessarily in combination with an osteosynthesis procedure (metallic plates and screws).
Cross.Bone is a resorbable, biphasic ceramic implant composed of 60% hydroxyapatite and 40% ß-tricalcium phosphate in the form of granules. It is used as a bone filler and for bone reconstruction.
This document is a 510(k) summary for a medical device called "Cross.Bone," a resorbable, biphasic ceramic implant used as a bone filler. It does not describe an AI/ML powered medical device. Therefore, it does not contain the information required to answer your prompt, such as acceptance criteria, study details, sample sizes, expert involvement, or grand truth methods related to AI/ML performance.
The document discusses the device's indications for use, description, and substantial equivalence to legally marketed predicate devices, which is a regulatory pathway for medical devices in the US that do not require an AI/ML component.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.