R-Genin Putty
R-GENIN is a resorbable bone void filler for gaps that do not determine the stability of the surrounding bone. It is gently packed into defects in the extremities, pelvis or posterolateral…
R-GENIN is a resorbable bone void filler for gaps that do not determine the stability of the surrounding bone. It is gently packed into defects in the extremities, pelvis or posterolateral spine, including defects created by surgery or traumatic injury.
The material provides a space-filling implant into which new bone can grow during healing. It is intended to resorb as new bone replaces the filler, and can be mixed with the patient’s own blood before use at the physician’s discretion.
Listed Item
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.
Composition
R-GENIN contains purified fibrillar bovine collagen, hydroxyapatite, tricalcium phosphate and demineralized bone matrix. The product is terminally sterilized by gamma irradiation.
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Allgens Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 1 |
Record
| 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
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RG-00P | In distribution | |
| RG-05P | In distribution | |
| RG-15P | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Synthacer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 360 |
| Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 357 |
| Biosorb | S.B.M | 65 |
| MagnetOs | Kuros Biosciences B.V | 61 |
| BioSet® | Rti Surgical, Inc. | 47 |
| Bicera® Resorbable Bone Substitute | Wiltrom Corporation Limited | 41 |
| GRAFTON®and Grafton PLUS®Demineralized Bone Matrix (DBM) | Medtronic Sofamor Danek, Inc. | 40 |
| Bicera® Resorbable Bone Substitute | Wiltrom Co., Ltd. (Chutung) | 39 |
| ChronOS | Synthes Gmbh | 39 |
| Synthacer/Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 36 |
| Inion BioRestore™ | Inion OY | 35 |
| Resorba Synthetic Bone | Biomatlante | 35 |
Showing 12 of 750. All products under Filler, Bone Void, Calcium Compound
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170917 | 2017-10-30 |
| K113791 | 2012-03-15 |
| K091912 | 2010-06-23 |
| K092046 | 2010-03-24 |
| K053213 | 2006-07-06 |
| K051914 | 2005-11-03 |
| K051695 | 2005-07-19 |
| K050666 | 2005-04-11 |
| K042636 | 2004-12-14 |
| K041889 | 2004-08-19 |
| K040405 | 2004-03-05 |
| K030266 | 2003-02-20 |
| K023703 | 2003-01-30 |
| K022622 | 2003-01-09 |
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.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-09-02 | Class II | Process control | Due to incorrect product label (Incorrect product name identified on outer packaging). | 62 units |
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.