# K181587: ORTHOLOC SPS Shoulder Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Oct 5, 2018 after 112 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 K100146 (2010). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 4.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 4.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 4.
- K082625: Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates, Synthes (Usa) (2008) Summary page 4.
- K100146: Evolve Eps Ortholoc, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K102352: Evolve Eps Ortholoc, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K111432: Evolve (R) Triad (TM)  Plating System and Evolve (R) Triad (TM) Bone Screws, Wrightmedicaltechnologyinc (2011) Summary page 4.

## Most influential descendants
- K191711: ORTHOLOC™ SPS Shoulder Plating System (2019), 0 descendants of its own

## Indications for use
The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K181587
Methodology: https://510kreport.com/methodology