# K100146: Evolve Eps Ortholoc

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Feb 2, 2010 after 14 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
No predicates in its family tree.
103 later devices descend from it; 2 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K102352: Evolve Eps Ortholoc (2010), 102 descendants of its own
- K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws (2012), 97 descendants of its own
- K121651: Ortholoc 3DI Midfoot/Flatfoot System (2012), 95 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K143025: Total Compression Plating System (2014), 24 descendants of its own

## Indications for use
The EVOLVE® BPS ORTHOLOC TM System is intended for fixation of fractures, osteotomies and nonunions of the olecranon, humerus, radius, ulna.

Source page: https://510kreport.com/device/K100146
Methodology: https://510kreport.com/methodology
