510(k) · Cleared
ClearedPolarcup 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 14, 2011 as substantially equivalent to K070278 (Plus Orthopedics AG, 2007) and 1 other predicate after a 269-day review. Its family tree reaches back 3 generations to 1999. 14 later devices descend from it.
- Decided
- Oct 14, 2011
- Review
- 269 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K991990 (1999). 4 ancestors in all. 14 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK991990 Tri-Polar SystemBiomet, Inc. · 1999
- 2 generations backK070278 Polarcup Dual Mobility SystemPlus Orthopedics AG · 2007
- 1 generation backK083116 Versafit Cup Double Mobility SystemMedacta International S.A. · 2009 · Recalled
- This deviceK110135 Polarcup Dual Mobility SystemSmith & Nephew, Inc. · 2011
- Descendant · cites it directly · 9 of its ownK171934 Birmingham Hip (BH) Dual Mobility InsertSmith & Nephew, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK191002 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019
- Descendant · cites it directly · 5 of its ownK122244 Polarcup Dual Mobility SystemSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK220959 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K171934Birmingham Hip (BH) Dual Mobility InsertSmith & Nephew, Inc. · 2017 · cites it directly9descendants
- K191002OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019 · cites it directly5descendants
- K122244Polarcup Dual Mobility SystemSmith & Nephew, Inc. · 2012 · cites it directly5descendants
- K220959OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991990 | Tri-Polar System | Biomet, Inc. | 1999 | — |
| −2 | K070278 | Polarcup Dual Mobility System | Plus Orthopedics AG | 2007 | — |
| −1 | K083116 | Versafit Cup Double Mobility System | Medacta International S.A. | 2009 | 2 |
| 0 (this device) | K110135 | Polarcup Dual Mobility System | Smith & Nephew, Inc. | 2011 | — |
| +1 | K171934 | Birmingham Hip (BH) Dual Mobility Insert | Smith & Nephew, Inc. | 2017 | — |
| +1 | K191002 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2019 | — |
| +1 | K122244 | Polarcup Dual Mobility System | Smith & Nephew, Inc. | 2012 | — |
| +1 | K220959 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2022 | — |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 24.2 · 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? (2)
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 |
|---|---|---|---|
| * | K070278 | Polarcup Dual Mobility SystemSummary page 1…LPH, KWY', JDI Predicate Devices: POLARCUP Dual Mobility System 510(k): K070278 Product Codes: LPH, KWVY… | 2007 |
| * | K083116 | Versafit Cup Double Mobility SystemSummary page 1…Codes: LPH, KWVY VERSAFIT Double Mobility System 510(k): K083116 Product Code: MEH Device Description The POLARCUP0 Dual Mobility System… | 2009 |
What descends from it? (14)
See all 147 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171934 | Birmingham Hip (BH) Dual Mobility Insert | 2017 | 9 |
| K191002 | OR3O Dual Mobility System | 2019 | 5 |
| K122244 | Polarcup Dual Mobility System | 2012 | 5 |
| K220959 | OR3O Dual Mobility System | 2022 | 3 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K181366 | REDAPT Porous Acetabular Shell | 2018 | 1 |
| K181491 | Delta Dual Mobility System | 2019 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K171934 (Smith & Nephew, Inc., 2017) has gone furthest, with 9 descendants of its own.
- 7 other devices also cite its predicate K070278.
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. 2011, 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 POLARCUP0 Dual Mobility System is indicated for:
* 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 fracture to hip joint
The POLARCUP0 Dual Mobility System is intended for single use only and depending on its version is to be implanted either with or without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110135: Polarcup 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/K110135
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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