# K080694: Osteomed Modular Locking Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: May 15, 2008 after 65 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: 4 generations back to K954385 (1996). 25 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063790: The Synthes Matrixmandible Plate and Screw System, Synthes (Usa) (2007) Summary page 1.
- K022185: Universal CMF System, Stryker Instruments (2002) Summary page 1.
- K032442: KLS-Martin Mandibular/Reconstruction System II, KLS-Martin L.P. (2003) Summary page 1.
- K911936: Osteomed SBF System (SBF), Osteomed Corp. (1991) Summary page 1.
- K924138: Osteomed M3 System (SBF System), Osteomed Corp. (1993) Summary page 1.
- K030448: Osteomed 2.0 Locking Plates and Screws, Osteomed LP (2003) Summary page 1.
- K063052: Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent Plates, Walter Lorenz Surgical, Inc. (2007) Summary page 1.

## Most influential descendants
- K182609: Delphos Implants Rigid Fixation System (2019), 0 descendants of its own
- K143338: Argulated Locking Plates (2015), 0 descendants of its own

## Indications for use
The OsteoMed Modular Locking Fixation System is intended for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The OsteoMed Modular Locking Fixation System implants and drills are intended for single use only,

Source page: https://510kreport.com/device/K080694
Methodology: https://510kreport.com/methodology