# K121651: Ortholoc 3DI Midfoot/Flatfoot System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 12, 2012 after 129 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: 9 generations back to K954385 (1996). 49 ancestors in all.
95 later devices descend from it; 13 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)
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 1.
- K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws, Wrightmedicaltechnologyinc (2012) Summary page 1.
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology, Orthohelix Surgical Designs, Inc. (2010) Summary page 1.
- K100502: Ascension Total Plate System, Ascension Orthopedics, Inc. (2010) Summary page 1.

## Cited in the summary but kept off the family tree
- K110663: Pairetex Optimized Composite Mesh (Pco-FX Refrences), Sofradim Production (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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

## Indications for use
The ORTHOLOC™ 3Di Midfoot/Flatfoot System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. Specific examples include: Flatfoot Osteotomies Lateral column Lengthening (Evans Osteotomy) Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) Medial Displacement Calcaneal Osteotomy (MDCO) Mid / Hindfoot Fusions LisFranc Arthrodesis and/or Stabilization 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions Intercuneiform Fusions Navicular-Cuneiform (NC) Fusion Talo-Navicular (TN) Fusion Calcaneo-Cuboid (CC) Fusion Medial Column Fusion

Source page: https://510kreport.com/device/K121651
Methodology: https://510kreport.com/methodology