# K012589: Fast Set Putty

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Feb 7, 2002 after 181 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
No predicates in its family tree.
17 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K041842: Norian SRS Fast Set Putty (2004), 10 descendants of its own
- K051603: Stryker Injectable Cement (2005), 3 descendants of its own
- K042072: Callos CMF Bone Void Filler (2004), 3 descendants of its own
- K140309: Cranioplug (2014), 2 descendants of its own
- K071004: Osteocrete Bone Void Filler (2009), 2 descendants of its own

## Indications for use
Fast Set Putty is indicated for repairing or filling craniofacial defects and craniotomy cuts with a surface area no larger than 25cm’. Fast Set Putty is also indicated for the restoration or augmentation of bony contours of the craniofacial skeleton, including the fronto-orbital, malar and mental areas.

Source page: https://510kreport.com/device/K012589
Methodology: https://510kreport.com/methodology