# K221933: MONTAGE Settable, Resorbable Bone Putty

- Pathway: 510(k) (Traditional)
- Applicant: Orthocon, Inc.
- Decided: Jan 13, 2023 after 196 days
- Product code: GXP (Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K873689 (1987). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060763: Stryker Injectable Cement, Stryker (2006) Summary page 4.

## Most influential descendants
- K253854: MONTAGE XT Cranial Cement (2026), 0 descendants of its own

## Indications for use
Orthocon MONTAGE Settable, Resorbable Bone Putty is a self-setting calctum phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm2. MONTAGE Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

Source page: https://510kreport.com/device/K221933
Methodology: https://510kreport.com/methodology