(89 days)
Cerasorb ORTHO in granular form is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb ORTHO granules are intended to be gently packed into the bony voids or gaps of the skeletal system. The material should not be packed in dry form, it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.
Cerasorb ORTHO granules have no weight-bearing capacity. Therefore, osteosynthetic measures may be required.
Following placement in the bony voids or gaps, the Beta-Tricalciumphosphate granules are gradually resorbed and substituted by vital, natural bone.
Cerasorb ORTHO is a porous resorbable bone void filler for the repair of bony defects. Chemically the material consists of pure phase Beta-Tricalciumphosphate, as described in the ASTM F 1088 - 87 (reapproved 1992). It is an osteoconductive implant with interconnected porosity. The implant is provided sterile in granular form, granular sizes being 500 - 1000um or 1000 - 2000 um.
When Cerasorb ORTHO is placed in the defect site with direct contact with the viable host bone, it guides the three-dimensional regeneration of bone. As the Cerasorb ORTHO granules resorbs, newly formed bone grows into the space previously occupied by the granular Beta-Tricalciumphosphate material. Cerasorb ORTHO was shown to have 90% or greater resorption in animal studies and was also shown to resorb well clinically.
Here's an analysis of the provided text regarding the Cerasorb ORTHO Synthetic Bone Void Filler, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for the subject device. As such, information typically found in a standalone clinical trial report (like detailed sample sizes for test sets, ground truth methodology for training, MRMC studies, or detailed performance metrics against specific acceptance criteria) is generally not present here. The performance is largely inferred from its similarity to the predicate device and general material properties.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for Cerasorb ORTHO are implicitly derived from its substantial equivalence to the predicate device, Vitoss™ Scaffold Synthetic. The following table summarizes the key performance attributes that indicate equivalence rather than explicit numerical acceptance criteria.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Cerasorb ORTHO) |
|---|---|
| Material Composition: Must be β-Tricalciumphosphate. | β-Tricalciumphosphate, Ca₃(PO₄)₂. Its chemical composition is consistent with ASTM F 1088 - 87 (reapproved 1992). |
| Structure: Porous, with interconnected porosity. | Interconnective porosity. Micropores >0 |
§ 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.