# K113339: Ortholoc 3DSI Locking Screws

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Dec 12, 2011 after 28 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: 2 generations back to K100146 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102352: Evolve Eps Ortholoc, Wrightmedicaltechnologyinc (2010) Summary page 1.

## Indications for use
EVOLVE® EPS ORTHOLOC™ System: Intended for fixation of fractures, osteotomies and nonunions of the olecranon, humerus, radius, and ulna

Source page: https://510kreport.com/device/K113339
Methodology: https://510kreport.com/methodology