PROSTIM Injectable Inductive Graft
FDA 510(k) K190283 · Wrightmedicaltechnologyinc
510(k) numberK190283
Submission
- Device name
- PROSTIM Injectable Inductive Graft
- Applicant
- Wrightmedicaltechnologyinc
Memphis, TN, US - Received
- February 11, 2019
- Decision date
- March 14, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 09/11/2026SE |
| K260364 | Device 300419 StripMQV · Traditional | Geistlich Pharma AG | 06/02/2026SE |
| K252797 | JAZBI Resorbable Bone Void FillerMQV · Traditional | Sdip Innovations Pty, Ltd. | 05/26/2026SE |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special | Stryker Spine | 04/24/2026SE |
| K253524 | Adaptos®Fuse Bone GraftMQV · Traditional | Biomendex OY | 02/17/2026SE |
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special | Prosidyan, Inc. | 10/22/2025SE |
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 10/13/2025SE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | Wright Medical Technology, Inc. (Stryker… | 09/30/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | Geistlich Pharma AG | 07/17/2025SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | SurGenTec, LLC | 07/02/2025SE |
More from SurGenTec, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K222835 | Prophecy Preoperative Navigation Alignment SystemHSN · Traditional | 01/27/2023SE |
| K213342 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 01/05/2022SE |
| K212996 | Sterile PHALINX Hammertoe SystemHWC · Traditional | 11/16/2021SE |
| K202815 | PROPHECY Preoperative Navigation Alignment SystemHSN · Traditional | 03/10/2021SE |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemHRS · Traditional | 01/08/2021SE |
| K200507 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 10/21/2020SE |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total…HSN · Traditional | 06/08/2020SE |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle SystemHSN · Traditional | 08/22/2019SE |
| K190970 | PROSTEP TBI (Tailors Bunion Implant) SystemHWC · Traditional | 08/13/2019SE |
| K183620 | PROSTEP TBC Implant SystemHRS · Traditional | 06/06/2019SE |
Questions and answers
When was PROSTIM Injectable Inductive Graft cleared by the FDA?
PROSTIM Injectable Inductive Graft (K190283) received a 510(k) decision of Substantially Equivalent on March 14, 2019, 31 days after the submission was received.
What is the product code of K190283?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.