# K152893: Corin Optimized Positioning System (OPS)

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Jun 3, 2016 after 247 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: 13 generations back to K810258 (1981). 147 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111863: Signature Planner,Signature Guides, Materialise NV (2012) Summary page 5.
- K093472: Trinity Acetabular System, Corin USA (2010) Summary page 3.
- K110087: Corin Trinity Acetbular System with Hxlpe Liners, Corin USA (2011) Summary page 3.
- K111481: Corin Trinity Acetabular System Ecima Liners, Corin USA (2012) Summary page 3.
- K122305: Corin Trinity-I Acetabular Shell, Corin USA (2012) Summary page 3.
- K123705: Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells, Corin USA (2013) Summary page 3.
- K130128: Trinity Acetabular System, Corin Medical (2013) Summary page 3.
- K130343: Corin Trinity Acetabular System with Extra-Long Heads, Corin USA (2013) Summary page 3.
- K131647: Trinity Acetabular System, Corin USA (2013) Summary page 3.
- (no number) Corin Instrument 510(k) Exempt (Product Code - KIL): named in the summary without a submission number

## Most influential descendants
- K190834: Corin Optimized Position System Functional Hip Analysis (OPS FHA) (2019), 5 descendants of its own
- K192656: Optimized Positioning System (OPS) Insight (2020), 3 descendants of its own
- K181061: Corin Optimized Positioning System (OPS) Femoral (2018), 1 descendant 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

## Indications for use
The Corin Optimized Positioning System (OPS) is intended to be used as patient-specific surgical instrument to assist in the alignment of components during total hip arthroplasty. The Corin OPS is intended to assist in the orientation of the acetabular cup intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative X-rays and CT imaging scans. The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty. The Corin Optimized Positioning System is intended for use with the Direct Anterior or Posterolateral surgical approaches. The Patient Specific Guides are intended for single use only.

Source page: https://510kreport.com/device/K152893
Methodology: https://510kreport.com/methodology
