510(k) Report

510(k) · Cleared

Cleared

Corin Optimized Positioning System (OPS™) Plan

K171847510(k) TraditionalCleared Apr 5, 2018288-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Corin U.S.A. Limited · LLZ System, Image Processing, Radiological

Cleared on Apr 5, 2018 as substantially equivalent to K133022 (Lexi Co., Ltd., 2014) after a 288-day review. Its family tree reaches back 9 generations to 1990. 6 later devices descend from it.

Decided
Apr 5, 2018
Review
288 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 9 generations to K896095 (1990). 12 ancestors in all. 6 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2000: 1 other ancestor1991: 1 other ancestor2020: 4 descendants cleared2018: 1 descendant cleared2021: 1 descendant clearedK896095 · Images-on-Call Teleradiology System · Devices & Services Co. · 1990K962699 · Radworks Medical Imaging Software · Applicare Medical Imaging, B.V. · 1996K982862 · Radworks Medical Imaging Software with Quality Control Module · Applicare Medical Imaging, B.V. · 1998K012211 · Efilm Workstation · Efilm Medical, Inc. · 2001 · recalledK020995 · Efilm Workstation with Modules · Efilm Medical, Inc. · 2002 · recalledK032401 · Orthoview · Omsbar, Ltd. · 2003K042816 · Traumacad 1.2 · Orthocrat, Ltd. · 2004K063327 · Orthoview · Merdian Technique, Ltd. · 2006K133022 · Zedview · Lexi Co., Ltd. · 20141990200020102020
Other ancestors, by generationDescendants, by generation 4 generations back: 1 other ancestor5 generations back: 1 other ancestor7 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 2 descendants K133022 · Zedview · Lexi Co., Ltd. · 2014K063327 · Orthoview · Merdian Technique, Ltd. · 2006K042816 · Traumacad 1.2 · Orthocrat, Ltd. · 2004K032401 · Orthoview · Omsbar, Ltd. · 2003K020995 · Efilm Workstation with Modules · Efilm Medical, Inc. · 2002 · recalledK012211 · Efilm Workstation · Efilm Medical, Inc. · 2001 · recalledK982862 · Radworks Medical Imaging Software with Quality Control Module · Applicare Medical Imaging, B.V. · 1998K962699 · Radworks Medical Imaging Software · Applicare Medical Imaging, B.V. · 1996K896095 · Images-on-Call Teleradiology System · Devices & Services Co. · 1990−50
  1. Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
  2. 5 generations between
  3. 3 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
  4. 2 generations backK063327 OrthoviewMerdian Technique, Ltd. · 2006
  5. 1 generation backK133022 ZedviewLexi Co., Ltd. · 2014
  6. This deviceK171847 Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited · 2018
  7. Descendant · cites it directly · 5 of its ownK183038 Corin Optimized Positioning System (OPS) PlanCorin USA · 2018
  8. Descendant · cites it directly · 3 of its ownK192656 Optimized Positioning System (OPS) InsightCorin USA · 2020
  9. Descendant · 2 generations on · 0 of its ownK210653 ONE Planner HipOrthosoft D/B/A Zimmer Cas · 2021
  10. Descendant · 2 generations on · 0 of its ownK202805 Optimized Positioning System (OPS) InsightCorin USA · 2020
  11. Descendant · cites it directly · 0 of its ownK193545 Corin Optimized Positioning System (OPS) FemoralCorin USA · 2020
Show all 9 generations
  1. Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
  2. 8 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
  3. 7 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
  4. 6 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
  5. 5 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
  6. 4 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
  7. 3 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
  8. 2 generations backK063327 OrthoviewMerdian Technique, Ltd. · 2006
  9. 1 generation backK133022 ZedviewLexi Co., Ltd. · 2014
  10. This deviceK171847 Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2018: 12020: 42021: 1
2018high 4 (2020) · low 0 (2019)2026

Most influential descendants

Showing 5 of 6 · See all
  • K183038Corin Optimized Positioning System (OPS) PlanCorin USA · 2018 · cites it directly5descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K896095Images-on-Call Teleradiology SystemDevices & Services Co.1990—
−8K962699Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V.1996—
−7K982862Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V.1998—
−6K012211Efilm WorkstationEfilm Medical, Inc.20011
−5K020995Efilm Workstation with ModulesEfilm Medical, Inc.20022
−4K032401OrthoviewOmsbar, Ltd.2003—
−3K042816Traumacad 1.2Orthocrat, Ltd.2004—
−2K063327OrthoviewMerdian Technique, Ltd.2006—
−1K133022ZedviewLexi Co., Ltd.2014—
0 (this device)K171847Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited2018—
+1K183038Corin Optimized Positioning System (OPS) PlanCorin USA2018—
+1K192656Optimized Positioning System (OPS) InsightCorin USA2020—
+2K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas2021—
+2K202805Optimized Positioning System (OPS) InsightCorin USA2020—
+1K193545Corin Optimized Positioning System (OPS) FemoralCorin USA2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200010
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202040
202110
FIG. 1 — Lineage of K171847, 1990–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K133022Zedview
Summary page 5
…– Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis . 9. Substantially Equivalent (predicate) device(s): • ZedView (K133022) 10. Device Description: The Corin Optimized Positioning System™ Plan (OPS™ Plan) is a pre-operative templating tool to a…
Lexi Co., Ltd.2014—

Also cleared against K133022: 3 other devices →

What descends from it? (6)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K183038Corin Optimized Positioning System (OPS) PlanCorin USA20185
K192656Optimized Positioning System (OPS) InsightCorin USA20203
K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200
K193042Optimized Positioning System (OPS) ReViewCorin USA20200

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 8 companies; a new generation was cleared every 2.2 years on median.
  • 2 of the 12 ancestors have a recall of any class.
  • Of its descendants, K183038 (Corin USA, 2018) has gone furthest, with 5 descendants of its own.
  • 3 other devices also cite its predicate K133022.

How does its category compare?

All LLZ devices

LLZ 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

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

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) Femoral Hip Stems.

Indications for use as stated in the FDA summary.

Also cleared against K133022

3 other devices cite the same predicate.

  • K211429NAVIPLAN - CT Planning Software for Total Hip ReplacementNaviswiss AG · 2021
  • K200704ZedViewLexi Co., Ltd. · 2021
  • K163405360KS Implant Positioning SystemKico Knee Innovation Company Pty Limited · 2017

More from Corin U.S.A. Limited

21 FDA decisions under this applicant name. See the company

  • K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited · 2025
  • K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited · 2025
  • K241472Icona Hip StemCorin U.S.A. Limited · 2024
  • K241570Unity Total Knee SystemCorin U.S.A. Limited · 2024
  • K240875Unity Knee PS-C Tibial InsertCorin U.S.A. Limited · 2024

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K171847 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171847: 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/K171847

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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