# K974555: Synthes 2.0 MM Locking Plate System (2.0 LPS)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 3, 1998 after 89 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: 1 generation back to K954385 (1996). 3 ancestors in all.
457 later devices descend from it; 7 cite it directly.
0 of 461 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954385: Synthes Mandibular Modular Fixation System, Synthes (Usa) (1996) Summary page 1.
- K961421: Synthes 2.4 MM Universal Locking Plate System, Synthes (Usa) (1996) Summary page 1.
- K963546: SMF Titanium (TI) Alloy Bone Screws, Synthes (Usa) (1997) Summary page 1.

## Most influential descendants
- K030448: Osteomed 2.0 Locking Plates and Screws (2003), 444 descendants of its own
- 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

## Indications for use
The Synthes 2.0 LPS is intended for oral, maxillofacial surgery: trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

Source page: https://510kreport.com/device/K974555
Methodology: https://510kreport.com/methodology