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 31, 2019 as substantially equivalent to K110135 (Smith & Nephew, Inc., 2011) and 3 other predicates after a 198-day review. Its family tree reaches back 6 generations to 1996. 5 later devices descend from it.
- Decided
- Oct 31, 2019
- Review
- 198 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K955033 (1996). 54 ancestors in all, the oldest K861766 (1986). 5 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 5 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 4 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 3 generations backK022958 Total Hip Femoral Heads and LinersSmith & Nephew, Inc. · 2002 · Recalled
- 2 generations backK081566 Smith & Nephew Oxinium DH Femoral HeadsSmith & Nephew, Inc. · 2008
- 1 generation backK161233 OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016
- This deviceK191002 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK220959 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK232667 OR3O Dual Mobility LinersSmith & Nephew, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK253948 Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
- Descendant · cites it directly · 0 of its ownK243456 ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK242375 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K220959OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K232667OR3O Dual Mobility LinersSmith & Nephew, Inc. · 2023 · cites it directly1descendant
- K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026 · 2 generations on0descendants
- K243456ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025 · cites it directly0descendants
- K242375OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −5 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −4 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −3 | K022958 | Total Hip Femoral Heads and Liners | Smith & Nephew, Inc. | 2002 | 1 |
| −2 | K081566 | Smith & Nephew Oxinium DH Femoral Heads | Smith & Nephew, Inc. | 2008 | — |
| −1 | K161233 | OXINIUM DH Fermoral Heads | Smith & Nephew, Inc. | 2016 | — |
| 0 (this device) | K191002 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2019 | — |
| +1 | K220959 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2022 | — |
| +1 | K232667 | OR3O Dual Mobility Liners | Smith & Nephew, Inc. | 2023 | — |
| +2 | K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026 | — |
| +1 | K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025 | — |
| +1 | K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 24.3 · 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 |
|---|---|---|---|
| * | K110135 | Polarcup Dual Mobility SystemSummary page 4…ed prosthesis, (21 CFR888.3358) III. PREDICATE DEVICE Primary Predicate: POLARCUP Dual Mobility System - K110135 (S.E. 10/14/2011) Predicate 2: REFLECTION Hip System – K071160 (S.E. 10/05/… | 2011 |
| * | K071160 | Reflection, Tandem UnipolarSummary page 4…UP Dual Mobility System - K110135 (S.E. 10/14/2011) Predicate 2: REFLECTION Hip System – K071160 (S.E. 10/05/2007) Predicate 3: BH Dual Mobility System - K171934 (S.E. 11/3… | 2007 |
| * | K171934 | Birmingham Hip (BH) Dual Mobility InsertSummary page 4…REFLECTION Hip System – K071160 (S.E. 10/05/2007) Predicate 3: BH Dual Mobility System - K171934 (S.E. 11/30/2017) Predicate 4: OXINIUM DH Femoral Heads - K161233 (S.E. 12/… | 2017 |
| * | K161233 | OXINIUM DH Fermoral HeadsSummary page 4…Dual Mobility System - K171934 (S.E. 11/30/2017) Predicate 4: OXINIUM DH Femoral Heads - K161233 (S.E. 12/14/2016) The predicate devices have not been subject to a design… | 2016 |
What descends from it? (5)
4 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 23 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 15 of the 54 ancestors have a recall of any class.
- Of its descendants, K220959 (Smith & Nephew, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K110135.
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. 2019, 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?
Intended Use The OR3O 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…
Read the full statement (123 words)
Intended Use
The OR3O 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 OR3O Dual Mobility System is intended for single use only. The modular OR3O Liners and Inserts are to be implanted without bone cement.
Mating components may be indicated for use without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K191002: OR3O Dual Mobility System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K191002
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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