# K120359: Ortholoc 3DI Hallux System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: May 3, 2012 after 87 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K022325 (2002). 2 ancestors in all.
84 later devices descend from it; 11 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own

## Recalls of this device
- Apr 10, 2023 · Class II · Z-1467-2023: Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
- Apr 10, 2023 · Class II · Z-1466-2023: Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.

## Indications for use
The ORTHOLOCm 3Di Hallux System is intended for use in stabilization and fixation of fresh fractures; revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include: * First metatarsal osteotomies for hallux valgus correction including: o Opening base wedge osteotomy o Closing base wedge osteotomy o Crescentic osteotorny o Proximal Chevron osteotomy o Distal Chevron osteotomy (Austin) * First metatarsal fracture fixation * Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) * Arthrodesis of the first metatarsophalangeal joint (MTP) including: o .Primary MTP Fusion due to hallux ridgidus and/or hallux valgus o Revision MTP Fusion o Revision of failed first MTP Arthropiasty implant

Source page: https://510kreport.com/device/K120359
Methodology: https://510kreport.com/methodology