# K021618: Osa Rigid Internal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Corp.
- Decided: Aug 8, 2002 after 84 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
Longest line of descent: 2 generations back to K953806 (1996). 3 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980199: Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws, Synthes (Usa) (1998) Summary page 1.
- K944565: KLS-Martin Micro Osteosythesis System (1.5MM), KLS-Martin L.P. (1994) Summary page 1.
- (no number) Leibinger Profil-0-Plastic, Titanium Implant System: named in the summary without a submission number

## Most influential descendants
- K031989: Ortrautek Orthognathic System (2003), 5 descendants of its own
- K091812: Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible Reconstruction and Mesh Systems (2010), 4 descendants of its own
- K141764: Tristar Bone Graft Fixation System (2014), 3 descendants of its own
- K170697: GBR system (2018), 2 descendants of its own
- K222367: Save GBR (2023), 0 descendants of its own

## Indications for use
OsteoMed OSA Rigid Internal Fixation System is intended for a variety of pan facial indications. Specifically, the system is intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and mandible. Implants are single use only.

Source page: https://510kreport.com/device/K021618
Methodology: https://510kreport.com/methodology