# K181843: MLP Special Locking Bone Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Maxxion Medical, LLC / Baumer SA
- Decided: Mar 4, 2019 after 236 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962616 (1996). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063460: Acumed Congruent Bone Plate System, Acumed, LLC (2006) Summary page 5.
- K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 5.
- K163293: Colink™ Plating System, In2bones USA, LLC (2017) Summary page 5.
- K083286: Orthopediatrics Pediloc Locking Plate System, OrthoPediatrics Corp. (2009) Summary page 5.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 5.

## Indications for use
The MLP Special Locking Bone Plate System is indicated for use in internal fixation for bone fractures, fusions, osteotomies, pseudoarthroses, and non-unions of the humerus, radius, ulna, tibia, scapula, clavicle, fibula, tarsal, metatarsal and metatarsophalangeal in pediatrics and adult populations.

Source page: https://510kreport.com/device/K181843
Methodology: https://510kreport.com/methodology