# K003788: Synthes Resorable Meshes and Sheets

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 30, 2001 after 173 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
34 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031961: Inion Otps Biodegradable Mesh Plating System (2004), 21 descendants of its own
- K123672: Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) (2013), 17 descendants of its own
- K160304: OsteoBullet Compression Screw (2016), 8 descendants of its own
- K022139: Hip Tool Implant (2002), 7 descendants of its own
- K193660: OSSIOfiber™ Compression Screws (2020), 6 descendants of its own

Source page: https://510kreport.com/device/K003788
Methodology: https://510kreport.com/methodology