# K093464: Rapidsorb Plus Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 25, 2010 after 80 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981666 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062789: Synthes (Usa) Rapid Resorbable Fixation System, Synthes (Usa) (2007) Summary page 1.
- K981666: 2.5 MM Lactosorb Screws, Biomet, Inc. (1998) Summary page 1.

## Indications for use
Synthes' RapidSorb PLUS screws are indicated for use as fixation in mandibular osteotomy procedures, including: * sagital split osteotomy * vertical ramus osteotomy *inferior border osteotomy *subapical. osteotomy *genioplasty.

Source page: https://510kreport.com/device/K093464
Methodology: https://510kreport.com/methodology