510(k) · Cleared
ClearedREDAPT Anteverted Cemented Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Nov 17, 2016 as substantially equivalent to K002747 (Smith & Nephew, Inc., 2000) and 1 other predicate after a 227-day review. Its family tree reaches back 5 generations to 1986. 4 later devices descend from it.
- Decided
- Nov 17, 2016
- Review
- 227 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K861766 (1986). 11 ancestors in all. 4 later devices descend from it, 1 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 deviceK160923 REDAPT Anteverted Cemented LinerSmith & Nephew, Inc. · 2016
- 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
Most influential descendants
Showing 4 of 4 · 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
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) | K160923 | REDAPT Anteverted Cemented Liner | Smith & Nephew, Inc. | 2016 | — |
| +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 |
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 |
|---|---|---|
| 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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 |
|---|---|---|---|
| * | K002747 | Reflection Cross-Linked Uhmwpe Acetabular ComponentsSummary page 5…Status REFLECTION Cross-Linked UHMWPE Primary for Smith & Nephew K002747 12/15/2000 Acetabular Components Cemented Liner… | 2000 |
| * | K150790 | REDAPT Porous Acetabular Shell and Cemented LinerSummary page 5…se only and is to be implanted with bone cement. The above indications are substantially equivalent to the indications cleared for the REDAPT Cemented Liners cleared in K150790. Technological Characteristics A review of the mechanical data indicates that the REDAPT Anteverted Cemented Liners are capable… | 2015 |
| † | K022902 | Smith & Nephew Hip System | 2002 |
| † | K113848 | R3 Xlpe Liners | 2012 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
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 30 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K211176 (Smith & Nephew, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 10 other devices also cite its predicate K002747.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
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 for…
Read the full statement (136 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.
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/K160923 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160923: REDAPT Anteverted Cemented Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160923
Report an extraction error
Are you the manufacturer?
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