FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute
FDA 510(k) K253147 · Prosidyan, Inc.
510(k) numberK253147
Submission
- Device name
- FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute
- Applicant
- Prosidyan, Inc.
New Providence, NJ, US - Received
- September 25, 2025
- Decision date
- October 22, 2025
- 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 |
| 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 |
| K251193 | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone GraftMQV · Traditional | Medtronic Sofamor Danek, Inc. | 06/12/2025SE |
More from Medtronic Sofamor Danek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251648 | GPS Advanced; GPS Advanced CannulaFMF · Special | 06/24/2025SE |
| K241426 | GPS Advanced; 5 cc GPS Advanced CannulaFMF · Traditional | 07/10/2024SE |
| K213803 | FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteMQV · Traditional | 08/23/2022SE |
| K182670 | FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteMQV · Traditional | 12/20/2018SE |
| K180080 | FIBERGRAFT BG Matrix Bone Graft SubstituteMQV · Traditional | 04/06/2018SE |
| K171284 | FIBERGRAFT BG Matrix Bone Graft SubstituteMQV · Traditional | 06/30/2017SE |
| K170306 | FIBERGRAFT BG Putty Bone Graft SubstituteMQV · Traditional | 05/24/2017SE |
| K151154 | FIBERGRAFT BG MorselsMQV · Traditional | 11/10/2015SE |
| K143533 | Fibergraft BG Putty Bone Graft SubstituteMQV · Traditional | 03/25/2015SE |
| K141956 | Fibergraft BG MorselsMQV · Special | 08/13/2014SE |
Questions and answers
When was FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute cleared by the FDA?
FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute (K253147) received a 510(k) decision of Substantially Equivalent on October 22, 2025, 27 days after the submission was received.
What is the product code of K253147?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.