# K141417: Charlotte (TM) MTP Bone Fusion Plate System Hex Screw

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jul 9, 2014 after 41 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K042205 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042205: Bone Fusion Plate System, Wrightmedicaltechnologyinc (2004) Summary page 1.

## Recalls of this device
- Dec 3, 2021 · Class II · Z-0401-2022: Incorrect product is contained in the packaging.

## Indications for use
The CHARLOTTE MTP Bone Fusion Plate System is intended to help increase the rate of bony union, and to maintain the position of the toe during fusion. Once the joint has fused, the plate is secondary in the transmission of gait forces. Indications for Use: * Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint * Deformity due to hallux valgus * Deformity due to arthritis in the first metatarsal-phalangeal joint * Loss of motion- hallux rigidus * Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsal-phalangeal joint * Revision procedures where other treatments or devices have failed: and * Chronic instability in the first metatarsal-phalangeal joint

Source page: https://510kreport.com/device/K141417
Methodology: https://510kreport.com/methodology