510(k) · Cleared
ClearedOptimized Positioning System (OPS) Insight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · LLZ System, Image Processing, Radiological
Cleared on May 1, 2020 as substantially equivalent to K173390 (Onefit Medical, 2018) and 3 other predicates after a 219-day review. Its family tree reaches back 15 generations to 1981. 3 later devices descend from it.
- Decided
- May 1, 2020
- Review
- 219 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K810258 (1981). 179 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations between
- 3 generations backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
- 2 generations backK152893 Corin Optimized Positioning System (OPS)Corin USA · 2016
- 1 generation backK190834 Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA · 2019
- This deviceK192656 Optimized Positioning System (OPS) InsightCorin USA · 2020
- Descendant · cites it directly · 0 of its ownK210653 ONE Planner HipOrthosoft D/B/A Zimmer Cas · 2021
- Descendant · cites it directly · 0 of its ownK202805 Optimized Positioning System (OPS) InsightCorin USA · 2020
- Descendant · cites it directly · 0 of its ownK193545 Corin Optimized Positioning System (OPS) FemoralCorin USA · 2020
Show all 15 generations
- Root · 15 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 14 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 13 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 12 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 11 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 10 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 9 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 8 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 7 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 6 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 5 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 4 generations backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
- 3 generations backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
- 2 generations backK152893 Corin Optimized Positioning System (OPS)Corin USA · 2016
- 1 generation backK190834 Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA · 2019
- This deviceK192656 Optimized Positioning System (OPS) InsightCorin USA · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −14 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −13 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −12 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −11 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −10 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −9 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −8 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −7 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −6 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −5 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −4 | K122305 | Corin Trinity-I Acetabular Shell | Corin USA | 2012 | — |
| −3 | K123705 | Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells | Corin USA | 2013 | 4 |
| −2 | K152893 | Corin Optimized Positioning System (OPS) | Corin USA | 2016 | — |
| −1 | K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | Corin USA | 2019 | — |
| 0 (this device) | K192656 | Optimized Positioning System (OPS) Insight | Corin USA | 2020 | — |
| +1 | K210653 | ONE Planner Hip | Orthosoft D/B/A Zimmer Cas | 2021 | — |
| +1 | K202805 | Optimized Positioning System (OPS) Insight | Corin USA | 2020 | — |
| +1 | K193545 | Corin Optimized Positioning System (OPS) Femoral | Corin USA | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 13 | 0 |
| 1995 | 8 | 0 |
| 1996 | 11 | 0 |
| 1997 | 11 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 17 | 0 |
| 2001 | 13 | 0 |
| 2002 | 13 | 0 |
| 2003 | 6 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173390 | hipEOSSummary page 5…ification Name: 21 CFR 892.2050 – Picture archiving and communications 9. Substantially Equivalent (predicate) device(s): • OneFIT Medical hipEOS (K173390) • Corin OPS™ Plan (K171847, K183038) • Corin OPS™ FHA (K190834) 10. Device Description: OPS™ Insight is an interacti… | 2018 |
| * | K171847 | Corin Optimized Positioning System (OPS™) PlanSummary page 5…50 – Picture archiving and communications 9. Substantially Equivalent (predicate) device(s): • OneFIT Medical hipEOS (K173390) • Corin OPS™ Plan (K171847, K183038) • Corin OPS™ FHA (K190834) 10. Device Description: OPS™ Insight is an interactive software for preoperative pla… | 2018 |
| * | K183038 | Corin Optimized Positioning System (OPS) PlanSummary page 5…ure archiving and communications 9. Substantially Equivalent (predicate) device(s): • OneFIT Medical hipEOS (K173390) • Corin OPS™ Plan (K171847, K183038) • Corin OPS™ FHA (K190834) 10. Device Description: OPS™ Insight is an interactive software for preoperative planning of… | 2018 |
| * | K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA)Summary page 5…s 9. Substantially Equivalent (predicate) device(s): • OneFIT Medical hipEOS (K173390) • Corin OPS™ Plan (K171847, K183038) • Corin OPS™ FHA (K190834) 10. Device Description: OPS™ Insight is an interactive software for preoperative planning of Total Hip Arthroplasty. It en… | 2019 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 39 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 38 of the 178 ancestors have a recall of any class.
- Of its descendants, K210653 (Orthosoft D/B/A Zimmer Cas, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K173390.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192656: Optimized Positioning System (OPS) Insight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192656
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026