510(k) · Cleared
ClearedR3 Xlpe Anteverted Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Cleared on Jan 19, 2011 as substantially equivalent to K070756 (Smith & Nephew, Inc., 2007) and 3 other predicates after a 152-day review. Its family tree reaches back 5 generations to 1986. 6 later devices descend from it.
- Decided
- Jan 19, 2011
- Review
- 152 days
- Class
- Class II
- Product code
- MBL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K861766 (1986). 46 ancestors in all. 6 later devices descend from it, 3 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 backK092386 R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009
- This deviceK102370 R3 Xlpe Anteverted LinersSmith & Nephew, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK182535 R3 Anteverted LinersSmith & Nephew, Inc. · 2018
- 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K182535R3 Anteverted LinersSmith & Nephew, Inc. · 2018 · cites it directly4descendants
- 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 | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners | Smith & Nephew, Inc. | 2009 | — |
| 0 (this device) | K102370 | R3 Xlpe Anteverted Liners | Smith & Nephew, Inc. | 2011 | — |
| +1 | K182535 | R3 Anteverted Liners | Smith & Nephew, Inc. | 2018 | — |
| +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 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 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 MBL? 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 MBL device
- #1 K201157 Prime BIOFOAM® Multi-Hole Shellsscore 3.7 · 7 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K070756 | Smith and Nephew Reflection 3 Acetabular SystemSummary page 2…nufacturer Description Number Date Smith &Nephew, Inc. Reflection 3Acetabular System K070756 6/6/07 Smith &Nephew, Inc. R3 Multi-Hole Shells and 36mm XLPE K092386 11/3/09… | 2007 |
| * | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSummary page 1…diameters of 32 and 36mn and outer diameters of 48-72fl4mm. R3 XLPE Acetabular Liners have previously been cleared for market under premarket notifications K(070756 and K092386 in liner options of 0*,00 lateralized +4mm, 200, and 200 lateralized +4mm. The subject R3 XLPE Anteverted Liners are very similar… | 2009 |
| * | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSummary page 2…d 36mm XLPE K092386 11/3/09 Acetabular Liners Smith &Nephew, Inc. CoCr and Oxinium Femoral Heads and R3 K093363 1/26/10 XLPE Liners ____________ DePuy Orthopaedics, In… | 2010 |
| * | K062148 | Depuy Pinnacle Altrx Acetabular Cup LinerSummary page 1…the subject R3 XLPE Anteverted Liners. Similar face changing liners have also been cleared for market by DePuy Orthopaedics, Inc. under premarket notification K062148. Intended Use Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or dev… | 2006 |
What descends from it? (6)
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 25 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 12 of the 46 ancestors have a recall of any class.
- Of its descendants, K182535 (Smith & Nephew, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 14 other devices also cite its predicate K070756.
How does its category compare?
All MBL devicesMBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MBL
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MBL
Too few MBL 510(k)s in any year since 2007 to give a median.
Recalls per year · MBL
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBL
41in 2025
MAUDE reports naming product code MBL, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 2 | 6 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 0 | — | 0 | 55 |
| 2016 | 1 | — | 0 | 54 |
| 2017 | 0 | — | 0 | 61 |
| 2018 | 1 | — | 0 | 112 |
| 2019 | 0 | — | 0 | 172 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 1 | — | 0 | 116 |
| 2022 | 0 | — | 0 | 90 |
| 2023 | 0 | — | 0 | 78 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 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 (NIDJDI 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 (134 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 (NIDJDI 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 Reflection 3 Acetabular System is for single use only and is intended for cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102370: R3 Xlpe Anteverted Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102370
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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