# K041350: Synthes (Usa) Chronos

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 8, 2004 after 49 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.
40 later devices descend from it; 2 cite it directly.
0 of 41 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 its predicate without a number.
- (no number) Norian Cranial Repair System (CRS) Bone Cement: named in the summary without a submission number
- (no number) Etex al-BSM Bone Substitute Material for Cranioplasty: named in the summary without a submission number

## Most influential descendants
- K063422: Bioaggregate (2006), 38 descendants of its own
- K080917: Iroot SP (2008), 37 descendants of its own
- K082943: Iroot BP, Model Irbp 4609 (2009), 12 descendants of its own
- K170175: Endoseal Mta (2018), 8 descendants of its own
- K092715: Iroot BP Plus (2009), 7 descendants of its own

## Indications for use
Synthes chronOS is intended for the repair or filling of craniofacial defects and craniotomy cuts with a surface area no larger than 25 cm2. It is also indicated for the restoration or augmentation of bony contours of the craniofacial skeleton, including the fronto-orbital, malar and mental areas. Synthes chronOS is intended to be gently packed or placed into the site. chronOS resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K041350
Methodology: https://510kreport.com/methodology