510(k) · Cleared
ClearedREDAPT Porous Acetabular Shell and Cemented Liner
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 16, 2015 as substantially equivalent to K050937 (Zimmer Trabecular, 2005) and 2 other predicates after a 236-day review. Its family tree reaches back 4 generations to 1986. 13 later devices descend from it.
- Decided
- Nov 16, 2015
- Review
- 236 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K861766 (1986). 10 ancestors in all. 13 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK861766 Howmedica Hoffmann Fixation Pin SystemHowmedica Corp. · 1986
- 3 generations backK964094 MinifixFerguson Medical · 1996
- 2 generations backK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
- 1 generation backK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
- This deviceK150790 REDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK171073 Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK182109 REDAPT Modular Acetabular ShellSmith & Nephew, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK160923 REDAPT Anteverted Cemented LinerSmith & Nephew, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · cites it directly · 1 of its ownK210614 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K171073Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc. · 2017 · cites it directly5descendants
- K182109REDAPT Modular Acetabular ShellSmith & Nephew, Inc. · 2018 · cites it directly4descendants
- K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc. · 2016 · cites it directly4descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K861766 | Howmedica Hoffmann Fixation Pin System | Howmedica Corp. | 1986 | — |
| −3 | K964094 | Minifix | Ferguson Medical | 1996 | — |
| −2 | K061253 | Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2006 | — |
| −1 | K070756 | Smith and Nephew Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2007 | 6 |
| 0 (this device) | K150790 | REDAPT Porous Acetabular Shell and Cemented Liner | Smith & Nephew, Inc. | 2015 | — |
| +1 | K171073 | Smith & Nephew, Inc. REDAPT Augments | Smith & Nephew, Inc. | 2017 | — |
| +1 | K182109 | REDAPT Modular Acetabular Shell | Smith & Nephew, Inc. | 2018 | — |
| +1 | K160923 | REDAPT Anteverted Cemented Liner | Smith & Nephew, Inc. | 2016 | — |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +1 | K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K050937 | Trabecular Metal Acetabular Revision ShellsSummary page 5…Status Zimmer Trabecular Trabecular Metal Acetabular Primary for K050937 5/11/2005 Metal Technology Revision Shells Porous Shell… | 2005 |
| * | K002747 | Reflection Cross-Linked Uhmwpe Acetabular ComponentsSummary page 5…ous Shell REFLECTION Cross-Linked UHMWPE Primary for Smith & Nephew K002747 12/15/2000 Acetabular Components Cemented Liner… | 2000 |
| * | K070756 | Smith and Nephew Reflection 3 Acetabular SystemSummary page 5…se only and is to be implanted with bone cement. The above indications are substantially equivalent to the indications cleared for the R3 acetabular shell cleared in K070756. Technological Characteristics A review of the mechanical data indicates that the REDAPT Porous Acetabular Shell and Cemented… | 2007 |
| † | K060630 | Reflection 3-Hole Shell with Asymmetric Porous Coating | 2006 |
| † | K962541 | Reflection Acetabular Reinforcement Rings | 1996 |
| † | K022902 | Smith & Nephew Hip System | 2002 |
| † | K113848 | R3 Xlpe Liners | 2012 |
What descends from it? (13)
See all 137 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171073 | Smith & Nephew, Inc. REDAPT Augments | 2017 | 5 |
| K182109 | REDAPT Modular Acetabular Shell | 2018 | 4 |
| K160923 | REDAPT Anteverted Cemented Liner | 2016 | 4 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K210614 | BENCOX Mirabo Z Cup Cortinium | 2022 | 1 |
| K181366 | REDAPT Porous Acetabular Shell | 2018 | 1 |
| K253630 | Mpact 3D Metal Foam | 2026 | 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 29 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K171073 (Smith & Nephew, Inc., 2017) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K050937.
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. 2015, 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 REDAPT Porous Acetabular Shell and Cemented Liner are indicated for: Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the…
Read the full statement (166 words)
The REDAPT Porous Acetabular Shell and Cemented Liner are indicated for:
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The REDAPT Porous Acetabular Shell is intended for single use only and is to be implanted without bone cement. The REDAPT Cemented Liner is intended for single use only and is to be implanted with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150790: REDAPT Porous Acetabular Shell and Cemented Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150790
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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