MONTAGE Settable, Resorbable Bone Putty
FDA 510(k) K221933 · Orthocon, Inc.
510(k) numberK221933
Submission
- Device name
- MONTAGE Settable, Resorbable Bone Putty
- Applicant
- Orthocon, Inc.
Irvington, NY, US - Received
- July 1, 2022
- Decision date
- January 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251959 | TnR Cranial ImplantGXP · Traditional | T&R BIOFAB CO., Ltd. | 07/30/2026SE |
| K261265 | Permatage XT Settable Bone PuttyGXP · Special | Orthocon, Inc. | 06/15/2026SE |
| K253732 | Permatage Flowable, Settable Bone PasteGXP · Traditional | Orthocon, Inc. | 03/13/2026SE |
| K253854 | MONTAGE XT Cranial CementGXP · Special | Orthocon, Inc. | 01/02/2026SE |
| K241027 | Permatage Settable Bone PuttyGXP · Traditional | Orthocon, Inc. | 09/26/2024SE |
| K232771 | Montage Flowable Settable, Resorbable Bone PasteGXP · Traditional | Orthocon, Inc. | 02/16/2024SE |
| K231475 | MONTAGE-QS Settable, Resorbable Bone PuttyGXP · Traditional | Orthocon, Inc. | 10/12/2023SE |
| K182742 | Db-CmfGXP · Traditional | Dimensional Bioceramics, LLC | 06/20/2019SE |
| K162864 | OsteoVation ImpactGXP · Traditional | Skeletal Kinetics, LLC | 01/13/2017SE |
| K143661 | DirectInjectGXP · Traditional | Stryker | 09/02/2015SE |
More from Stryker
| 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, Resorbable Bone Putty cleared by the FDA?
MONTAGE Settable, Resorbable Bone Putty (K221933) received a 510(k) decision of Substantially Equivalent on January 13, 2023, 196 days after the submission was received.
What is the product code of K221933?
The FDA product code is GXP – Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.