# K022844: Synthes Resorbable Contourable Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 7, 2003 after 133 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Synthes Resorbable Fixation System devices (Plates, Meshes, Screws and Tacks), are intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Resorbable Meshes, Sheets, Screws, and Tacks may be used in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft) or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.

Source page: https://510kreport.com/device/K022844
Methodology: https://510kreport.com/methodology