# K200062: Foot and Ankle System

- Pathway: 510(k) (Traditional)
- Applicant: Leith Medical, LLC
- Decided: Feb 22, 2021 after 406 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
Longest line of descent: 16 generations back to K962616 (1996). 155 ancestors in all.
No later device cites it as a predicate yet.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102429: Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K131093: Ortholoc (R) 3DI Ankle Plating System, Wrightmedicaltechnologyinc (2013) Summary page 4.
- K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System, Wrightmedicaltechnologyinc (2015) Summary page 4.
- K120359: Ortholoc 3DI Hallux System, Wrightmedicaltechnologyinc (2012) Summary page 4.
- K060514: Stryker Plating System, Howmedica Osteonics Corp. (2006) Summary page 4.
- K121601: Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate, Synthes USA (2012) Summary page 4.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 4.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 4.
- K191009: Arsenal Plating System, Trilliant Surgical (2019) Summary page 4.

## Indications for use
The Leith Medical Ankle Fracture Plates are intended and designed for open reduction, internal fixation of ankle fractures, revision of ankle fractures, as well as osteotomies, and non-unions of the distal tibia and fibula. The Leith Medical First Tarsal-Metatarsal Joint (1st TMT) Arthrodesis Plates are intended and designed for primary arthrodesis of the 1st TMT joint due to degenerative joint disease and/or halluxvalgus, or revision of prior 1st TMT joint arthrodesis. The Leith Medical Medial Malleolar Fracture Plates are intended and designed for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula. The Leith Medical First Metatarsal Phalangeal Joint Arthrodesis Plates are intended and designed for primary arthrodesis of the 1st MTP joint due to degenerative joint disease and/or hallux valgus, revision of prior 1st MTP joint arthrodesis, or revision of failed 1st MTP joint implant arthroplasty. The Leith Medical Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

Source page: https://510kreport.com/device/K200062
Methodology: https://510kreport.com/methodology