510(k) · Cleared
ClearedSmith & Nephew, Inc. REDAPT Augments
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 21, 2017 as substantially equivalent to K962541 (Smith & Nephew Richards, Inc., 1996) and 1 other predicate after a 224-day review. Its family tree reaches back 5 generations to 1986. 5 later devices descend from it.
- Decided
- Nov 21, 2017
- Review
- 224 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K861766 (1986). 12 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK861766 Howmedica Hoffmann Fixation Pin SystemHowmedica Corp. · 1986
- 4 generations backK964094 MinifixFerguson Medical · 1996
- 3 generations backK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
- 2 generations backK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
- 1 generation backK150790 REDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc. · 2015
- This deviceK171073 Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc. · 2017
- 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 ownK190847 REDAPT Blade AugmentsSmith & Nephew, Inc. · 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
- K190847REDAPT Blade AugmentsSmith & Nephew, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K861766 | Howmedica Hoffmann Fixation Pin System | Howmedica Corp. | 1986 | — |
| −4 | K964094 | Minifix | Ferguson Medical | 1996 | — |
| −3 | K061253 | Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2006 | — |
| −2 | K070756 | Smith and Nephew Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2007 | 6 |
| −1 | K150790 | REDAPT Porous Acetabular Shell and Cemented Liner | Smith & Nephew, Inc. | 2015 | — |
| 0 (this device) | K171073 | Smith & Nephew, Inc. REDAPT Augments | Smith & Nephew, Inc. | 2017 | — |
| +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 | K190847 | REDAPT Blade Augments | Smith & Nephew, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K962541 | Reflection Acetabular Reinforcement RingsSummary page 4…e Devices: Manufacturer Description 510(k) Clearance Date Smith & Nephew, Inc. Contour Acetabular Rings (Primary) K962541 09/17/1996 Smith & Nephew, Inc. REDAPT Porous Shell K150790 11/16/2015 Stryker… | 1996 |
| * | K150790 | REDAPT Porous Acetabular Shell and Cemented LinerSummary page 4…Clearance Date Smith & Nephew, Inc. Contour Acetabular Rings (Primary) K962541 09/17/1996 Smith & Nephew, Inc. REDAPT Porous Shell K150790 11/16/2015 Stryker RESTORATION Acetabular Wedge K102019 03/03/2011… | 2015 |
| † | K102019 | Restoration Acetabular Wedge Augments | 2011 |
| † | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners | 2009 |
| † | K070756 | Smith and Nephew Reflection 3 Acetabular System | 2007 |
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 31 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K211176 (Smith & Nephew, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K962541.
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?
• 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…
Read the full statement (189 words)
• 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.
REDAPT™ Augments are intended for single use only and are to be implanted with bone cement to the mating acetabular shell and without bone cement to the bone interface
Augments are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171073: Smith & Nephew, Inc. REDAPT Augments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171073
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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