R-GENIN is a bone void filler consisting of purified bovine collagen, hydroxyapatite, tri-calcium phosphate, and demineralized bone matrix (DBM). The collagen component is biocompatible.…
R-GENIN is a bone void filler consisting of purified bovine collagen, hydroxyapatite, tri-calcium phosphate, and demineralized bone matrix (DBM). The collagen component is biocompatible. After it is implanted, it resorbs and is later replaced by natural bone. R-GENIN is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous blood prior to use at the physician’s discretion.
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1).
Record
Regulatory record for R-Genin Strip | Listed by | Berkeley Advanced Biomaterials, United States |
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Manufacturer |
| 510(k) | K113791 |
| Record published | 2016-04-10 |
| Record revised | 2019-12-23 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.