# K080295: Charlotte Claw 3.5

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Feb 27, 2008 after 23 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.
138 later devices descend from it; 2 cite it directly.
0 of 139 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 no predicate by number.

## Most influential descendants
- K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws (2012), 97 descendants of its own
- K121651: Ortholoc 3DI Midfoot/Flatfoot System (2012), 95 descendants of its own
- K092528: Biomet Forerunner Locking Plate System (2010), 53 descendants of its own
- K113048: Maxlock Extreme System (2012), 52 descendants of its own
- K122005: Maxlock Extreme System (2012), 39 descendants of its own

## Recalls of this device
- 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.
- Jun 7, 2010 · Not classified · Z-2188-2010: One lot of CLAW Hex Foot and Ankle Screws was incorrectly packaged containing Multi-use Compression Screws.

## Indications for use
The CHARLOTTETM CLAW® 3.5 is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

Source page: https://510kreport.com/device/K080295
Methodology: https://510kreport.com/methodology