# K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 31, 2012 after 112 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K954385 (1996). 47 ancestors in all.
97 later devices descend from it; 2 cite it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102352: Evolve Eps Ortholoc, Wrightmedicaltechnologyinc (2010) Summary page 1.
- K051908: Charlotte Compression Plate, Wrightmedicaltechnologyinc (2005) Summary page 1.
- K080295: Charlotte Claw 3.5, Wrightmedicaltechnologyinc (2008) Summary page 1.
- K093914: Newdeal Compression Plates, Newdeal Sas (2011) Summary page 2.
- K091614: Osteomed Foot Plating System, Osteomed LP (2009) Summary page 2.
- K101240: Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467, DePuy Orthopaedics, Inc. (2010) Summary page 2.
- K083843: Locking Anatomic & Composite Plating System, DePuy Orthopaedics, Inc. (2009) Summary page 2.
- K073624: Modular Foot System, Orthohelix Surgical Designs, Inc. (2008) Summary page 2.
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology, Orthohelix Surgical Designs, Inc. (2010) Summary page 2.

## Most influential descendants
- K121651: Ortholoc 3DI Midfoot/Flatfoot System (2012), 95 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K143025: Total Compression Plating System (2014), 24 descendants of its own
- K151442: Total Compression Plating (TCP) System (2015), 23 descendants of its own
- K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System (2015), 22 descendants of its own

## Recalls of this device
- Feb 2, 2023 · Class II · Z-1169-2023: Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. P
- Feb 2, 2023 · Class II · Z-1170-2023: Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. P
- Dec 3, 2021 · Class II · Z-0392-2022: The incorrect product is contained in the packaging.
- 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.

## Indications for use
The CLAW® 11 Polyaxial Compression Plating System is intended to be used for fixation such as: * Midfoot and hindfoot arthrodeses or osteotomies * Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocubid, Lapidus) * Intercuneiform arthrodeses * Naviculocuneiform arthrodeses * Talonavicular arthrodeses * Calcaneocuboid arthrodeses * Lisfranc arthrodeses * Mono- or bi-cortical osteotomies in the forefoot, midfoot and hindfoot * Fixation of osteotomies for hallux valgus treatment (Scarf and Chevron) * Akin osteotomies * First metatarsophalangeal arthrodeses

Source page: https://510kreport.com/device/K113014
Methodology: https://510kreport.com/methodology