Montage Settable Bone Putty
FDA 510(k) K242050 · Orthocon, Inc.
510(k) numberK242050
Submission
- Device name
- Montage Settable Bone Putty
- Applicant
- Orthocon, Inc.
Stamford, CT, US - Received
- July 12, 2024
- Decision date
- July 29, 2024
- 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 |
|---|---|---|
| K262769 | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)MTJ · Special | 09/03/2026SE |
| K261265 | Permatage XT Settable Bone PuttyGXP · Special | 06/15/2026SE |
| K261439 | Permatage Flowable, Settable Hemostatic Bone PasteMTJ · Traditional | 06/03/2026SE |
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)GXR · Traditional | 03/16/2026SE |
| K253732 | Permatage Flowable, Settable Bone PasteGXP · Traditional | 03/13/2026SE |
| K253854 | MONTAGE XT Cranial CementGXP · Special | 01/02/2026SE |
| K243526 | MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty…MQV · Special | 12/05/2024SE |
| K243506 | Montage-XT Settable Bone PuttyMQV · Special | 11/18/2024SE |
| K241027 | Permatage Settable Bone PuttyGXP · Traditional | 09/26/2024SE |
| K233566 | Montage-XT Settable, Resorbable Bone PuttyMQV · Traditional | 08/21/2024SE |
Questions and answers
When was Montage Settable Bone Putty cleared by the FDA?
Montage Settable Bone Putty (K242050) received a 510(k) decision of Substantially Equivalent on July 29, 2024, 17 days after the submission was received.
What is the product code of K242050?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.