# K193545: Corin Optimized Positioning System (OPS) Femoral

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Aug 4, 2020 after 228 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: 16 generations back to K810258 (1981). 211 ancestors in all.
No later device cites it as a predicate yet.
0 of 211 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181061: Corin Optimized Positioning System (OPS) Femoral, Corin USA (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.
- K192656: Optimized Positioning System (OPS) Insight, Corin USA (2020). Cleared while this submission was under review Summary page 5.

## Indications for use
The Corin OPS™ Femoral is intended to be used as a patient-specific surgical instrument to assist the surgeon in delivering a target femoral neck osteotomy, based on a pre-operative plan with implant sizing, type and placement. The Corin OPS™ Femoral is intended to be used with OPS™ Insight, Corin OPS™ Plan and compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-situ Femoral Guide is intended for use with the direct anterior surgical approach. The Corin OPS™ Femoral PSI is intended for single use only.

Source page: https://510kreport.com/device/K193545
Methodology: https://510kreport.com/methodology