# K192656: Optimized Positioning System (OPS) Insight

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: May 1, 2020 after 219 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). 179 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173390: hipEOS, Onefit Medical (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.

## Most influential descendants
- K210653: ONE Planner Hip (2021), 0 descendants of its own
- K202805: Optimized Positioning System (OPS) Insight (2020), 0 descendants of its own
- K193545: Corin Optimized Positioning System (OPS) Femoral (2020), 0 descendants of its own

## Indications for use
OPS™ Insight is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

Source page: https://510kreport.com/device/K192656
Methodology: https://510kreport.com/methodology