# K190834: Corin Optimized Position System Functional Hip Analysis (OPS FHA)

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Jul 22, 2019 after 112 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K810258 (1981). 148 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152893: Corin Optimized Positioning System (OPS), Corin USA (2016) Summary page 5.

## Most influential descendants
- K192656: Optimized Positioning System (OPS) Insight (2020), 3 descendants of its own
- 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
- K193042: Optimized Positioning System (OPS) ReView (2020), 0 descendants of its own

## Indications for use
The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) is indicated for preoperative analysis of primary total hip arthroplasty. Corin OPS™ FHA is intended to be used as a pre-operative tool which provides the Surgeon with functional acetabular cup orientations based on the patient pelvic kinematics and presents a visualisation of the patient’s hemipelvis. The Corin OPS™ FHA is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.

Source page: https://510kreport.com/device/K190834
Methodology: https://510kreport.com/methodology