510(k) · Cleared
ClearedCorin Optimized Position System Functional Hip Analysis (OPS FHA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jul 22, 2019 as substantially equivalent to K152893 (Corin USA, 2016) after a 112-day review. Its family tree reaches back 14 generations to 1981. 5 later devices descend from it.
- Decided
- Jul 22, 2019
- Review
- 112 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K810258 (1981). 148 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations between
- 3 generations backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
- 2 generations backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
- 1 generation backK152893 Corin Optimized Positioning System (OPS)Corin USA · 2016
- This deviceK190834 Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA · 2019
- 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 · 2 generations on · 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 14 generations
- Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 13 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 12 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 11 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 10 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 9 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 8 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 7 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 6 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 5 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 4 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 3 generations backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
- 2 generations backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
- 1 generation backK152893 Corin Optimized Positioning System (OPS)Corin USA · 2016
- This deviceK190834 Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA · 2019
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 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −14 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −13 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −12 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −11 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −10 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −9 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −8 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −7 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −6 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −5 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −4 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −3 | K122305 | Corin Trinity-I Acetabular Shell | Corin USA | 2012 | — |
| −2 | K123705 | Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells | Corin USA | 2013 | 4 |
| −1 | K152893 | Corin Optimized Positioning System (OPS) | Corin USA | 2016 | — |
| 0 (this device) | K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | Corin USA | 2019 | — |
| +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 | — |
| +2 | 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 |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 12 | 0 |
| 1995 | 8 | 0 |
| 1996 | 10 | 0 |
| 1997 | 11 | 0 |
| 1998 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 16 | 0 |
| 2001 | 9 | 0 |
| 2002 | 10 | 0 |
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 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 |
|---|---|---|---|
| * | K152893 | Corin Optimized Positioning System (OPS)Summary page 5….3350 - Hip joint metal/polymer semi-constrained cemented prosthesis Substantially Equivalent (predicate) device(s): • Corin Optimized Positioning System (OPSTM) (K152893) Device description The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) consists of a pre-operative patie… | 2016 |
What descends from it? (5)
2 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 38 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 33 of the 147 ancestors have a recall of any class.
- Of its descendants, K192656 (Corin USA, 2020) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K152893.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) is indicated for preoperative analysis of primary total hip arthroplasty. Corin OPS™ FHA is intended to be used as a pre-operative tool which provides the Surgeon with functional acetabular cup orientations based on the patient pelvic kinematics and presents a visualisation of the patient’s hemipelvis.
The Corin OPS™ FHA is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190834 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190834: Corin Optimized Position System Functional Hip Analysis (OPS FHA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190834
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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