# K042205: Bone Fusion Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Sep 20, 2004 after 35 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HALLU®Plate System: named in the summary without a submission number

## Most influential descendants
- K141417: Charlotte (TM) MTP Bone Fusion Plate System Hex Screw (2014), 0 descendants of its own

## Indications for use
The 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 hallus 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/K042205
Methodology: https://510kreport.com/methodology