# K120802: Ortholoc (TM) 3DI Locking Screws Ortholoc (TM) Bone Screws

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Apr 2, 2012 after 17 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: 3 generations back to K082320 (2008). 4 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 16 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 1.
- K112772: Ortholoc (TM) Bone Screws, Wrightmedicaltechnologyinc (2011)

## Most influential descendants
- K151235: Medline Foot Plates and Screws (2015), 10 descendants of its own
- K181820: Medline Unite Mini Plates and Screws (2018), 2 descendants of its own
- K234031: Medline UNITE Ancillary Foot Recon Plating System (2024), 1 descendant of its own
- K202959: PolyLock Plating System (2020), 1 descendant of its own
- K162829: Medline UNITE® Ankle Fracture Plating System (2016), 1 descendant of its own

## Indications for use
Wright's ORTHOLOC 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as: * Lateral Malleolar Fractures * Syndesmosis injuries * Medial Malleolar Fractures * Bi-Malleolar Fractures * Tri-Malleolar Fractures * Posterior Malleolar Fractures * Distal Anterior Tibia Fractures * Vertical Shear Fractures of the Medial Malleolous * Pilon Fractures * Distal Tibia Shaft Fractures * Distal Fibula Shaft Fractures * Distal Tibia Periarticular Fractures * Medial Malledlar Avulsion Fractures * Lateral Malleolar Avusion Fractures The ORTHOLOC 3Di locking screws are intended for use with Wright's ORTHOLOC 3Di Plating Systems of the same base material. ORTHOLOC Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device. Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

Source page: https://510kreport.com/device/K120802
Methodology: https://510kreport.com/methodology