510(k) · Cleared
ClearedR3 Multi-Hole Shells and 36MM Xlpe Acetabular 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 Nov 3, 2009 as substantially equivalent to K061253 (Smith & Nephew, Inc., 2006) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1986. 46 later devices descend from it.
- Decided
- Nov 3, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- MBL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K861766 (1986). 9 ancestors in all. 46 later devices descend from it, 11 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 deviceK092386 R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- Descendant · 2 generations on · 16 of its ownK143407 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014
- Descendant · 2 generations on · 14 of its ownK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- Descendant · 3 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- Descendant · cites it directly · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · cites it directly25descendants
- K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014 · 2 generations on16descendants
- K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014 · 2 generations on14descendants
- K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 3 generations on9descendants
- K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · cites it directly7descendants
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) | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners | Smith & Nephew, Inc. | 2009 | — |
| +1 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| +2 | K143407 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2014 | — |
| +2 | K141972 | Klassic HD Acetabular Insert with E-Link Poly | Total Joint Orthopedics, Inc. | 2014 | — |
| +3 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
| +1 | K122185 | U-Motion II Acetabular System | United Orthopedic Corp. | 2013 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K061253 | Reflection 3 Acetabular SystemSummary page 1…~~~~~Submisinl ClearanceC Mpuacuer Dsrption. i~F~ubr Dt Smith & Nephew, Inc. fReflection 3 Acetabular System IK061253 5/31/06 Smith & Nephew, Inc. Reflection 3 Acetabular System K070756 6/6/07… | 2006 |
| * | K070756 | Smith and Nephew Reflection 3 Acetabular SystemSummary page 1…Dt Smith & Nephew, Inc. fReflection 3 Acetabular System IK061253 5/31/06 Smith & Nephew, Inc. Reflection 3 Acetabular System K070756 6/6/07 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Ser… | 2007 |
What descends from it? (46)
See all 4611 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100445 | Klassic HD Hip System | 2010 | 25 |
| K122185 | U-Motion II Acetabular System | 2013 | 7 |
| K113848 | R3 Xlpe Liners | 2012 | 7 |
| K102370 | R3 Xlpe Anteverted Liners | 2011 | 6 |
| K110101 | Taper Oxinium Femoral Head | 2011 | 5 |
| K182109 | REDAPT Modular Acetabular Shell | 2018 | 4 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip… | 2024 | 0 |
| K211330 | R3 Large Head Liners | 2022 | 0 |
| K201701 | R3 HA Coated Acetabular Shells | 2020 | 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 23 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K100445 (Total Joint Orthopedics, Inc., 2010) has gone furthest, with 25 descendants of its own.
- 10 other devices also cite its predicate K061253.
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. 2009, 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 INIDJD) 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 (158 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 INIDJD) 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; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; 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/K092386 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092386: R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092386
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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