# K193042: Optimized Positioning System (OPS) ReView

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Jun 26, 2020 after 239 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K810258 (1981). 182 ancestors in all.
No later device cites it as a predicate yet.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172346: sterEOS Workstation, Eos Imaging (2018) Summary page 5.
- K171847: Corin Optimized Positioning System (OPS™) Plan, Corin U.S.A. Limited (2018) Summary page 5.
- K183038: Corin Optimized Positioning System (OPS) Plan, Corin USA (2018) Summary page 5.
- K190834: Corin Optimized Position System Functional Hip Analysis (OPS FHA), Corin USA (2019) Summary page 5.

## Indications for use
OPSReView™ is intended to be used as a postoperative tool for visualising and quantifying component alignment to aid in the analysis of hip alignment following hip replacement surgery. OPSReView™ provides the surgeon with information relating to the in-situ implant placement as well as associated functional analysis and 3D biomechanical measurements, based on landmarks derived from patient specific postoperative imaging.

Source page: https://510kreport.com/device/K193042
Methodology: https://510kreport.com/methodology