(240 days)
GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal system (ie the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
GranOS™ is a porous, resorbable osteoconductive scaffold constructed of highly pure beta tricalcium phosphate granules for use in the repair of bony defects.
This document is a 510(k) Premarket Notification for a medical device called GranOS™ - beta tricalcium phosphate synthetic bone granules. It establishes substantial equivalence to legally marketed predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic or prognostic performance. The information provided does not describe a clinical study in the typical sense of measuring diagnostic accuracy or treatment effectiveness with human subjects.
Therefore, the requested information elements related to diagnostic performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for a diagnostic AI device are not applicable to this document. This document focuses on the technical and safety characteristics for regulatory approval as a bone void filler.
However, I can extract the relevant information from the document regarding the device's technical characteristics and how it meets regulatory standards for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like bone void fillers, "acceptance criteria" are typically defined by recognized standards and comparison to predicate devices, focusing on material properties, biocompatibility, and intended use. The performance is then demonstrated through non-clinical testing to meet these standards and show equivalence to predicates.
| Acceptance Criteria / Characteristic Type | Specific Criteria / Predicate Values | Reported Device Performance (GranOS™) |
|---|---|---|
| Chemical Composition | Beta tricalcium phosphate Ca3(PO4)2 meeting ASTM F 1088-04a (2010) | Beta tricalcium phosphate Ca3(PO4)2 meeting ASTM F 1088-04a (2010), same as predicates |
| Patient Population | Individuals with bony defects resulting from surgery or trauma | Individuals with bony defects resulting from surgery or trauma, same as predicates |
| Anatomical Locations | Bony voids/gaps in extremities, posterolateral spine, and pelvis | To be packed into irregular shaped bony voids of the skeletal system (extremities, spine, pelvis), same as predicates |
| Physical Structure | Interconnected porosity (most predicates) / Trabecular structure (one predicate) | Interconnected porosity |
| Porosity | Approximately 70% (two predicates) / 60-70% (one predicate) / 90% (one predicate) | Approximately 70% |
| Pore Size | 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.