Class Class II
MONTAGE Settable, Resorbable Bone Putty (K222063)
Description
MONTAGE Settable, Resorbable Bone Putty by Orthocon, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222063
Clearance Date2023-02-03
Clearance TypeTraditional
Product CodeMQV
Regulation Number888.3045
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222063
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. MONTAGE Settable, Resorbable Bone Putty (K222063) cites 1 predicate device and is itself cited by 4 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161447 | HydroSet XT | Orthovita, Inc. | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243526 | MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settabl... | Orthocon, Inc. | 2024 |
| K233566 | Montage-XT Settable, Resorbable Bone Putty | Orthocon, Inc. | 2024 |
| K242050 | Montage Settable Bone Putty | Orthocon, Inc. | 2024 |
| K231903 | Montage-QS Settable, Resorbable Bone Putty | Orthocon, Inc. | 2023 |
Trace the full predicate network for K222063
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.