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 Aug 23, 2012 as substantially equivalent to K120211 (Smith & Nephew, Inc., 2012) and 1 other predicate after a 27-day review. Its family tree reaches back 5 generations to 1994. 5 later devices descend from it.
- Decided
- Aug 23, 2012
- Review
- 27 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K932481 (1994). 10 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 4 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 3 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- 2 generations backK072852 SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc. · 2008
- 1 generation backK120211 SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc. · 2012
- This deviceK122244 Polarcup Dual Mobility SystemSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK240783 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular…Smith & Nephew, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK242375 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK231448 TANDEM Hip SystemSmith & Nephew, Inc. · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK181491 Delta Dual Mobility SystemLima Corporate S.P.A. · 2019
Most influential descendants
Showing 5 of 5 · See all- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc. · 2024 · 2 generations on0descendants
- K242375OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024 · 2 generations on0descendants
- K231448TANDEM Hip SystemSmith & Nephew, Inc. · 2023 · 2 generations on0descendants
- K181491Delta Dual Mobility SystemLima Corporate S.P.A. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −4 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −3 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| −2 | K072852 | SL-Plus Standard and Lateral Hip Stems | Smith & Nephew, Inc. | 2008 | — |
| −1 | K120211 | SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K122244 | Polarcup Dual Mobility System | Smith & Nephew, Inc. | 2012 | — |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +2 | K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners… | Smith & Nephew, Inc. | 2024 | — |
| +2 | K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2024 | — |
| +2 | K231448 | TANDEM Hip System | Smith & Nephew, Inc. | 2023 | 1 |
| +1 | K181491 | Delta Dual Mobility System | Lima Corporate S.P.A. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K120211 | SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSummary page 2…Dt Orth&paesA SL-PLUS' Standard and Lateral Femoral Stems K120211 7/19/12 Smth&pewA Orth&paesA POLARCUP Dual Mobility System K110135 10A4/111… | 2012 |
| * | K110135 | Polarcup Dual Mobility SystemSummary page 2…SL-PLUS' Standard and Lateral Femoral Stems K120211 7/19/12 Smth&pewA Orth&paesA POLARCUP Dual Mobility System K110135 10A4/111 All tests which are in relation to the surface characterization (physical, chemical or mechanical) are discusse… | 2011 |
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 18 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K211176 (Smith & Nephew, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K120211.
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. 2012, 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 POLARCUP 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…
Read the full statement (106 words)
The POLARCUP 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 titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement. The POLARCUP Dual Mobility System is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122244: 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/K122244
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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