510(k) · Cleared
ClearedBirmingham Hip (BH) Dual Mobility Insert
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 Nov 30, 2017 as substantially equivalent to K110135 (Smith & Nephew, Inc., 2011) and 1 other predicate after a 155-day review. Its family tree reaches back 4 generations to 1999. 9 later devices descend from it.
- Decided
- Nov 30, 2017
- Review
- 155 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K991990 (1999). 5 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK991990 Tri-Polar SystemBiomet, Inc. · 1999
- 3 generations backK070278 Polarcup Dual Mobility SystemPlus Orthopedics AG · 2007
- 2 generations backK083116 Versafit Cup Double Mobility SystemMedacta International S.A. · 2009 · Recalled
- 1 generation backK110135 Polarcup Dual Mobility SystemSmith & Nephew, Inc. · 2011
- This deviceK171934 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 · 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
- Descendant · 2 generations on · 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
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K191002OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019 · cites it directly5descendants
- K220959OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K232667OR3O Dual Mobility LinersSmith & Nephew, Inc. · 2023 · 2 generations on1descendant
- K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991990 | Tri-Polar System | Biomet, Inc. | 1999 | — |
| −3 | K070278 | Polarcup Dual Mobility System | Plus Orthopedics AG | 2007 | — |
| −2 | K083116 | Versafit Cup Double Mobility System | Medacta International S.A. | 2009 | 2 |
| −1 | K110135 | Polarcup Dual Mobility System | Smith & Nephew, Inc. | 2011 | — |
| 0 (this device) | K171934 | Birmingham Hip (BH) Dual Mobility Insert | Smith & Nephew, Inc. | 2017 | — |
| +1 | K191002 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2019 | — |
| +1 | K220959 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2022 | — |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +2 | K232667 | OR3O Dual Mobility Liners | Smith & Nephew, Inc. | 2023 | — |
| +2 | K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 24.2 · 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 |
|---|---|---|---|
| * | K110135 | Polarcup Dual Mobility SystemSummary page 4…t femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (CFR 888.3390), KWY III. PREDICATE DEVICE Primary Predicate - K110135 (S.E. 10/14/2011) POLARCUP Dual Mobility System Predicate 2 - K070278 (S.E.… | 2011 |
| * | K070278 | Polarcup Dual Mobility SystemSummary page 4…II. PREDICATE DEVICE Primary Predicate - K110135 (S.E. 10/14/2011) POLARCUP Dual Mobility System Predicate 2 - K070278 (S.E. 04/16/2007) POLARCUP Dual Mobility System The predicate device… | 2007 |
What descends from it? (9)
3 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 4 companies; a new generation was cleared every 6.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K191002 (Smith & Nephew, Inc., 2019) has gone furthest, with 5 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. 2017, 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 BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171934: Birmingham Hip (BH) Dual Mobility Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171934
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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