510(k) · Cleared
ClearedREDAPT Porous Acetabular Shell
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 Sep 24, 2018 as substantially equivalent to K150790 (Smith & Nephew, Inc., 2015) and 3 other predicates after a 124-day review. Its family tree reaches back 11 generations to 1981. 1 later device descends from it.
- Decided
- Sep 24, 2018
- Review
- 124 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K810258 (1981). 75 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
- 2 generations backK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
- 1 generation backK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
- This deviceK181366 REDAPT Porous Acetabular ShellSmith & Nephew, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK242744 Trinity EVO Acetabular ShellCorin U.S.A. Limited · 2025
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 4 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 3 generations backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
- 2 generations backK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
- 1 generation backK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
- This deviceK181366 REDAPT Porous Acetabular ShellSmith & Nephew, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −4 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −3 | K101336 | E1 Avantage Head | Biomet Manufacturing Corp | 2011 | 1 |
| −2 | K110555 | Arcomxl Active Articulation | Biomet Manufacturing Corp | 2011 | 2 |
| −1 | K150522 | G7 Dual Mobility System | Biomet, Inc. | 2015 | 1 |
| 0 (this device) | K181366 | REDAPT Porous Acetabular Shell | Smith & Nephew, Inc. | 2018 | — |
| +1 | K242744 | Trinity EVO Acetabular Shell | Corin U.S.A. Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K150790 | REDAPT Porous Acetabular Shell and Cemented LinerSummary page 4…r cemented or uncemented prosthesis (888-3390) KWY PREDICATE DEVICE Primary Predicate REDAPT Porous Acetabular Shells: K150790 (S.E. 11/16/2015) Predicate 2: POLARCUP Dual Mobility System: K… | 2015 |
| * | K110135 | Polarcup Dual Mobility SystemSummary page 4…REDAPT Porous Acetabular Shells: K150790 (S.E. 11/16/2015) Predicate 2: POLARCUP Dual Mobility System: K110135 (S.E. 10/14/2011) Predicate 3: G7 Dual Mobility System: K150522… | 2011 |
| * | K150522 | G7 Dual Mobility SystemSummary page 4…icate 2: POLARCUP Dual Mobility System: K110135 (S.E. 10/14/2011) Predicate 3: G7 Dual Mobility System: K150522 (S.E. 05/01/2015) Predicate 4: Trabecular Metal Acetabular Revision System… | 2015 |
| * | K072121 | Trabecular Metal Acetabular Revision System Cemented Contrained LinerSummary page 4…2 (S.E. 05/01/2015) Predicate 4: Trabecular Metal Acetabular Revision System Cemented Constrained Liner K072121 (S.E. 01/07/2008) The predicate devices have not been subject to a design… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242744 | Trinity EVO Acetabular Shell | 2025 | 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 37 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 20 of the 75 ancestors have a recall of any class.
- Of its descendants, K242744 (Corin U.S.A. Limited, 2025) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K150790.
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. 2018, 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?
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…
Read the full statement (106 words)
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 REDAPT Porous Acetabular Shell for use with the POLACUP Dual Mobility System is intended for single use only and is to be implanted without bone cement. The POLARCUP Dual Mobility System is to be implanted in the REDAPT Porous Acetabular Shell with 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/K181366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181366: REDAPT Porous Acetabular Shell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181366
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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