510(k) · Cleared
ClearedOptimized Positioning System (OPS) ReView
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 Jun 26, 2020 as substantially equivalent to K172346 (Eos Imaging, 2018) and 3 other predicates after a 239-day review. Its family tree reaches back 15 generations to 1981.
- Decided
- Jun 26, 2020
- Review
- 239 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K810258 (1981). 182 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK193042 Optimized Positioning System (OPS) ReViewCorin 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 deviceK193042 Optimized Positioning System (OPS) ReViewCorin USA · 2020
View 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) | K193042 | Optimized Positioning System (OPS) ReView | 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 | 14 | 0 |
| 2002 | 13 | 0 |
| 2003 | 6 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 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 |
|---|---|---|---|
| * | K172346 | sterEOS WorkstationSummary page 5…FR 888.3350 - Hip joint metal/polymer semi-constrained cemented Prosthesis 9. Substantially Equivalent (predicate) device(s): • Eos Imaging SterEOS Workstation (K172346). • Corin OPS™ Plan (K171847, K183038). • Corin OPS™ FHA (K190834) 10. Device Description: OPSReView™ is an image analy… | 2018 |
| * | K171847 | Corin Optimized Positioning System (OPS™) PlanSummary page 5…ymer semi-constrained cemented Prosthesis 9. Substantially Equivalent (predicate) device(s): • Eos Imaging SterEOS Workstation (K172346). • Corin OPS™ Plan (K171847, K183038). • Corin OPS™ FHA (K190834) 10. Device Description: OPSReView™ is an image analysis tool that provides surgeons w… | 2018 |
| * | K183038 | Corin Optimized Positioning System (OPS) PlanSummary page 5…-constrained cemented Prosthesis 9. Substantially Equivalent (predicate) device(s): • Eos Imaging SterEOS Workstation (K172346). • Corin OPS™ Plan (K171847, K183038). • Corin OPS™ FHA (K190834) 10. Device Description: OPSReView™ is an image analysis tool that provides surgeons with post-… | 2018 |
| * | K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA)Summary page 5…is 9. Substantially Equivalent (predicate) device(s): • Eos Imaging SterEOS Workstation (K172346). • Corin OPS™ Plan (K171847, K183038). • Corin OPS™ FHA (K190834) 10. Device Description: OPSReView™ is an image analysis tool that provides surgeons with post- operative information regarding… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 42 of the 181 ancestors have a recall of any class.
- 2 other devices also cite its predicate K172346.
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?
OPSReView™ is intended to be used as a postoperative tool for visualising and quantifying component alignment to aid in the analysis of hip alignment following hip replacement surgery.
OPSReView™ provides the surgeon with information relating to the in-situ implant placement as well as associated functional analysis and 3D biomechanical measurements, based on landmarks derived from patient specific postoperative imaging.
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/K193042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193042: Optimized Positioning System (OPS) ReView.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193042
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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