# K980199: Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 17, 1998 after 87 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 K953806 (1996). 1 ancestor in all.
10 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953806: Synthes (Usa) Midfacial System, Synthes (Usa) (1996) Summary page 1.

## Most influential descendants
- K021618: Osa Rigid Internal Fixation System (2002), 6 descendants of its own
- 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

## Indications for use
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, they are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Source page: https://510kreport.com/device/K980199
Methodology: https://510kreport.com/methodology