510(k) · Cleared
ClearedCorin Optimized Positioning System (OPS) Plan
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 Nov 26, 2018 as substantially equivalent to K171847 (Corin U.S.A. Limited, 2018) after a 25-day review. Its family tree reaches back 10 generations to 1990. 5 later devices descend from it.
- Decided
- Nov 26, 2018
- Review
- 25 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K896095 (1990). 13 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations between
- 3 generations backK063327 OrthoviewMerdian Technique, Ltd. · 2006
- 2 generations backK133022 ZedviewLexi Co., Ltd. · 2014
- 1 generation backK171847 Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited · 2018
- This deviceK183038 Corin Optimized Positioning System (OPS) PlanCorin USA · 2018
- Descendant · cites it directly · 3 of its ownK192656 Optimized Positioning System (OPS) InsightCorin USA · 2020
- Descendant · 2 generations on · 0 of its ownK210653 ONE Planner HipOrthosoft D/B/A Zimmer Cas · 2021
- Descendant · 2 generations on · 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
- Descendant · cites it directly · 0 of its ownK193042 Optimized Positioning System (OPS) ReViewCorin USA · 2020
Show all 10 generations
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 8 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 7 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 6 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 5 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 4 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 3 generations backK063327 OrthoviewMerdian Technique, Ltd. · 2006
- 2 generations backK133022 ZedviewLexi Co., Ltd. · 2014
- 1 generation backK171847 Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited · 2018
- This deviceK183038 Corin Optimized Positioning System (OPS) PlanCorin USA · 2018
Most influential descendants
Showing 5 of 5 · See all- K192656Optimized Positioning System (OPS) InsightCorin USA · 2020 · cites it directly3descendants
- K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas · 2021 · 2 generations on0descendants
- K202805Optimized Positioning System (OPS) InsightCorin USA · 2020 · 2 generations on0descendants
- K193545Corin Optimized Positioning System (OPS) FemoralCorin USA · 2020 · cites it directly0descendants
- K193042Optimized Positioning System (OPS) ReViewCorin USA · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −9 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −8 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −7 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −6 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −5 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −4 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −3 | K063327 | Orthoview | Merdian Technique, Ltd. | 2006 | — |
| −2 | K133022 | Zedview | Lexi Co., Ltd. | 2014 | — |
| −1 | K171847 | Corin Optimized Positioning System (OPS™) Plan | Corin U.S.A. Limited | 2018 | — |
| 0 (this device) | K183038 | Corin Optimized Positioning System (OPS) Plan | Corin USA | 2018 | — |
| +1 | K192656 | Optimized Positioning System (OPS) Insight | Corin USA | 2020 | — |
| +2 | K210653 | ONE Planner Hip | Orthosoft D/B/A Zimmer Cas | 2021 | — |
| +2 | K202805 | Optimized Positioning System (OPS) Insight | Corin USA | 2020 | — |
| +1 | K193545 | Corin Optimized Positioning System (OPS) Femoral | Corin USA | 2020 | — |
| +1 | K193042 | Optimized Positioning System (OPS) ReView | Corin USA | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 4 | 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? (1)
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 |
|---|---|---|---|
| * | K171847 | Corin Optimized Positioning System (OPS™) PlanSummary page 5…nonporous uncemented prosthesis. 9. Substantially Equivalent (predicate) device(s): • Corin Optimized Positioning System (OPS™) Plan (K171847) 10. Device Description: The Corin Optimized Positioning System™ Plan (OPS™ Plan) is a pre-operative… | 2018 |
What descends from it? (5)
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 28 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K192656 (Corin USA, 2020) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K171847.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The Corin Optimized Positioning System Plan (OPS™ Plan) is indicated for pre-operative planning for primary total hip arthroplasty. OPS™ Plan is intended to be used as a pre-operative tool to assist the Surgeon in the selection (for example, lateralised or standard stem), sizing and positioning of components of primary total hip arthroplasty.
The Corin OPS™ Plan is intended to be used with the Corin TriFit TS (K121563, K153772), MetaFix (K082525, K121439, K131952, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) and TriFit CF (K173880) Femoral Hip Stems.
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/K183038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183038: Corin Optimized Positioning System (OPS) Plan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183038
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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