# K163039: ORTHOLOC® 3Di Small Bones Plating

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Mar 13, 2017 after 133 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: 1 generation back to K090692 (2009). 1 ancestor in all.
15 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090692: Ortholoc 2.0/2.4 Plate System, Wrightmedicaltechnologyinc (2009) Summary page 4.

## Most influential descendants
- K203817: Tyber Medical Anatomical Plating System (2021), 10 descendants of its own
- K222465: Tyber Medical Anatomical Plating System (2023), 9 descendants of its own
- K232652: Anatomical Plating System (various) (2023), 3 descendants of its own
- K241218: Tyber Medical Anatomical Plating System (2024), 2 descendants of its own
- K233423: Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System (2023), 2 descendants of its own

## Indications for use
The ORTHOLOC® 3Di Small Bones Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes. The system can be used in both adult and pediatric patients. Examples include: - Metatarsal, metacarpal, or phalangeal fractures and osteotomies - Lesser metatarsal shortening osteotomies (e.g. Weil) - Fifth metatarsal fractures (e.g. Jones Fracture)

Source page: https://510kreport.com/device/K163039
Methodology: https://510kreport.com/methodology
