(200 days)
Stimulan Kit/Stimulan Rapid Cure is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created from traumatic injury to the bone. Stimulan Kit/Stimulan Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, and posterolateral spine). Stimulan Rapid Cure provides a bone graft substitute that resorbs and is replaced with bone during the healing process. Stimulan Rapid Cure is biodegradable and biocompatible and may be used at an infected site.
To fill a bone void or defect created by:
- . surgery
- . a cyst
- a tumour .
- . osteomyelitis
- . traumatic injury
Stimulan Kit/Stimulan Rapid Cure are indicated to be implanted into defects not intrinsic to the structural stability of the skeletal system. Stimulan Kit/Stimulan Rapid Cure are biocompatible and may be implanted at an infected site. Stimulan Kit/Stimulan Rapid Cure are presented as a powder and mixing solution which when mixed together form a paste which may be injected, digitally implanted or applied to the mold provided to produce pellets.
This document is a 510(k) premarket notification for the Stimulan Kit/Stimulan Rapid Cure, a bone void filler. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document explicitly states in section 9, "Clinical performance data was not required as the labelling modifications do not affect the safety and effectiveness of the modified device." This indicates that a new study to assess performance or acceptance criteria was not conducted for this specific submission, as the changes were limited to labeling and did not impact safety or effectiveness.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on existing data and regulatory requirements for labeling modifications, rather than presenting new performance data against acceptance criteria.
§ 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.