# K030448: Osteomed 2.0 Locking Plates and Screws

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: May 9, 2003 after 87 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 K954385 (1996). 7 ancestors in all.
444 later devices descend from it; 4 cite it directly.
0 of 452 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974555: Synthes 2.0 MM Locking Plate System (2.0 LPS), Synthes (Usa) (1998) Summary page 1.
- K000594: Locking Screw Mandibular Reconstruction Plate, Stryker Leibinger (2000) Summary page 1.
- K014263: Newgen/Universal Mandibular System, Stryker Instruments (2002)

## Most influential descendants
- K032442: KLS-Martin Mandibular/Reconstruction System II (2003), 435 descendants of its own
- K040598: KLS Martin Hand Plating System (2004), 360 descendants of its own
- K050868: Maxlock (2005), 343 descendants of its own
- K073624: Modular Foot System (2008), 342 descendants of its own
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology (2010), 339 descendants of its own

## Indications for use
Indicated for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). 2.0 Locking plates and screws are intended for single patient use only.

Source page: https://510kreport.com/device/K030448
Methodology: https://510kreport.com/methodology