510(k) · Cleared
ClearedOR3O Dual Mobility System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Oct 7, 2024 as substantially equivalent to K220959 (Smith & Nephew, Inc., 2022) and 3 other predicates after a 59-day review. Its family tree reaches back 10 generations to 1981.
- Decided
- Oct 7, 2024
- Review
- 59 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K810258 (1981). 186 ancestors in all, the oldest K791125 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 6 generations between
- 3 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 2 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 1 generation backK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- This deviceK242375 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 7 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 6 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 5 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 4 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 3 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 2 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 1 generation backK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- This deviceK242375 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −9 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −8 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −7 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −6 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −5 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −4 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −3 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −2 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| 0 (this device) | K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 3 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 3 | 0 |
| 1992 | 6 | 0 |
| 1993 | 3 | 0 |
| 1994 | 15 | 0 |
| 1995 | 6 | 0 |
| 1996 | 13 | 0 |
| 1997 | 12 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 10 | 0 |
| 2001 | 2 | 0 |
| 2002 | 11 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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 |
|---|---|---|---|
| * | K220959 | OR3O Dual Mobility SystemSummary page 5…on Number 888.3358 Product Code(s) LPH |Legaly Mareled Predcate Devices 21 CFR80T2a)0) Predicale # Predicate Trade Name (Primary Predicate is listed first) Product Code K220959 OR30 Dual Mobility System LPH K191002 OR30 Dual Mobility System LPH K232667 OR30 Dual Mobility Liners LPH K211176 Smith & Nephew… | 2022 |
| * | K191002 | OR3O Dual Mobility SystemSummary page 5…|Legaly Mareled Predcate Devices 21 CFR80T2a)0) Predicale # Predicate Trade Name (Primary Predicate is listed first) Product Code K220959 OR30 Dual Mobility System LPH K191002 OR30 Dual Mobility System LPH K232667 OR30 Dual Mobility Liners LPH K211176 Smith & Nephew Hip Systems - MR Labeling and DesignCh… | 2019 |
| * | K232667 | OR3O Dual Mobility LinersSummary page 5…CFR80T2a)0) Predicale # Predicate Trade Name (Primary Predicate is listed first) Product Code K220959 OR30 Dual Mobility System LPH K191002 OR30 Dual Mobility System LPH K232667 OR30 Dual Mobility Liners LPH K211176 Smith & Nephew Hip Systems - MR Labeling and DesignChanql JoI K232375 Page… | 2023 |
| * | K211176 | Smith & Nephew Hip SystemsSummary page 5…e Name (Primary Predicate is listed first) Product Code K220959 OR30 Dual Mobility System LPH K191002 OR30 Dual Mobility System LPH K232667 OR30 Dual Mobility Liners LPH K211176 Smith & Nephew Hip Systems - MR Labeling and DesignChanql JoI K232375 Page 2 of 3 The OR30 Hip System was origin… | 2022 |
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 43 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 44 of the 185 ancestors have a recall of any class.
- 2 other devices also cite its predicate K220959.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The OR30 Dual Mobility System is intended for use in primary and revision total hip arthroplasty in skeletally mature patients. Indications Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis. Fracture or avascular necrosis of the femoral head. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip…
Read the full statement (105 words)
The OR30 Dual Mobility System is intended for use in primary and revision total hip arthroplasty in skeletally mature patients.
Indications
Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis.
Fracture or avascular necrosis of the femoral head.
Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
All forms of osteoarthritis.
Patients with hips at risk of dislocation.
Femoral neck fracture or proximal hip joint fracture.
The OR30 Dual Mobility System is intended for single use only. The modular OR30 Liners and Inserts are to be implanted without bone cement.
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/K242375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242375: OR3O Dual Mobility System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242375
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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