# K133715: Charlotte Claw Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Feb 28, 2014 after 85 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Aug 18, 2026 · Class II · Z-3334-2026: Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid en
- Jul 30, 2014 · Class II · Z-2608-2014: Plates manufactured from an incorrect raw material.
- Jul 30, 2014 · Class II · Z-2601-2014: Plates manufactured from an incorrect raw material.
- Jul 30, 2014 · Class II · Z-2604-2014: Plates manufactured from an incorrect raw material.
- Jul 30, 2014 · Class II · Z-2603-2014: Plates manufactured from an incorrect raw material.
- Jul 30, 2014 · Class II · Z-2600-2014: Plates manufactured from an incorrect raw material.
- Jul 30, 2014 · Class II · Z-2599-2014: Plates manufactured from an incorrect raw material.
- Jul 30, 2014 · Class II · Z-2602-2014: Plates manufactured from an incorrect raw material.
- Jul 30, 2014 · Class II · Z-2607-2014: Plates manufactured from an incorrect raw material.
- Jul 30, 2014 · Class II · Z-2605-2014: Plates manufactured from an incorrect raw material.

Source page: https://510kreport.com/device/K133715
Methodology: https://510kreport.com/methodology