510(k) · Cleared
ClearedONE Planner Hip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthosoft D/B/A Zimmer Cas · LLZ System, Image Processing, Radiological
Cleared on Jul 7, 2021 as substantially equivalent to K192656 (Corin USA, 2020) after a 125-day review. Its family tree reaches back 16 generations to 1981.
- Decided
- Jul 7, 2021
- Review
- 125 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K810258 (1981). 180 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations between
- 3 generations backK152893 Corin Optimized Positioning System (OPS)Corin USA · 2016
- 2 generations backK190834 Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA · 2019
- 1 generation backK192656 Optimized Positioning System (OPS) InsightCorin USA · 2020
- This deviceK210653 ONE Planner HipOrthosoft D/B/A Zimmer Cas · 2021
Show all 16 generations
- Root · 16 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 15 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 14 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 13 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 12 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 11 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 10 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 9 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 8 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 7 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 6 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 5 generations backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
- 4 generations backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
- 3 generations backK152893 Corin Optimized Positioning System (OPS)Corin USA · 2016
- 2 generations backK190834 Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA · 2019
- 1 generation backK192656 Optimized Positioning System (OPS) InsightCorin USA · 2020
- This deviceK210653 ONE Planner HipOrthosoft D/B/A Zimmer Cas · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −15 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −14 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −13 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −12 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −11 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −10 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −9 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −8 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −7 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −6 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −5 | K122305 | Corin Trinity-I Acetabular Shell | Corin USA | 2012 | — |
| −4 | K123705 | Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells | Corin USA | 2013 | 4 |
| −3 | K152893 | Corin Optimized Positioning System (OPS) | Corin USA | 2016 | — |
| −2 | K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | Corin USA | 2019 | — |
| −1 | K192656 | Optimized Positioning System (OPS) Insight | Corin USA | 2020 | — |
| 0 (this device) | K210653 | ONE Planner Hip | Orthosoft D/B/A Zimmer Cas | 2021 | — |
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 |
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 |
|---|---|---|---|
| * | K192656 | Optimized Positioning System (OPS) InsightSummary page 4…58 Predicate Device(s): Manufacturer Device Name 510(k) Number Corin Corin Optimized Positioning System Insight K192656 K210653 Page 2/3 Purpose and Device… | 2020 |
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 40 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 38 of the 179 ancestors have a recall of any class.
- 2 other devices also cite its predicate K192656.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
ONE Planner™ Hip is intended for use as preoperative surgical planning software to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210653: ONE Planner Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210653
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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