510(k) · Cleared
ClearedR3 Large Head Liners
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 Jan 19, 2022 as substantially equivalent to K113848 (Smith & Nephew, Inc., 2012) and 3 other predicates after a 261-day review. Its family tree reaches back 6 generations to 1986.
- Decided
- Jan 19, 2022
- Review
- 261 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K861766 (1986). 47 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK861766 Howmedica Hoffmann Fixation Pin SystemHowmedica Corp. · 1986
- 5 generations backK964094 MinifixFerguson Medical · 1996
- 4 generations backK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
- 3 generations backK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
- 2 generations backK092386 R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009
- 1 generation backK113848 R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · Recalled
- This deviceK211330 R3 Large Head LinersSmith & Nephew, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K861766 | Howmedica Hoffmann Fixation Pin System | Howmedica Corp. | 1986 | — |
| −5 | K964094 | Minifix | Ferguson Medical | 1996 | — |
| −4 | K061253 | Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2006 | — |
| −3 | K070756 | Smith and Nephew Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2007 | 6 |
| −2 | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners | Smith & Nephew, Inc. | 2009 | — |
| −1 | K113848 | R3 Xlpe Liners | Smith & Nephew, Inc. | 2012 | 2 |
| 0 (this device) | K211330 | R3 Large Head Liners | Smith & Nephew, Inc. | 2022 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K113848 | R3 Xlpe LinersSummary page 5…he R3 Large Head Liners are a line extension to the existing R3 Acetabular System. The R3 Large Head Liners were previously cleared for market via premarket notification K113848. The head size of the liners are being increased to include sizes 28mm X 44mm, 32mm X 46mm, and 36mm X 50mm (inner diameter and o… | 2012 |
| * | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSummary page 5…espectively) in 0 and 20-degree versions. The R3 Large Head Liners are intended for single use only. Similar head sizes have been cleared on R3 XLPE 36mm XLPE Liners via K092386, R3 40 and 44mm XLPE Liners via K093363, and REFLECTION 32mm X 50-52mm XLPE Acetabular Liner via K002747. Indications for Use… | 2009 |
| * | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSummary page 5…. The R3 Large Head Liners are intended for single use only. Similar head sizes have been cleared on R3 XLPE 36mm XLPE Liners via K092386, R3 40 and 44mm XLPE Liners via K093363, and REFLECTION 32mm X 50-52mm XLPE Acetabular Liner via K002747. Indications for Use Hip components are indicated for indivi… | 2010 |
| * | K002747 | Reflection Cross-Linked Uhmwpe Acetabular ComponentsSummary page 5…lar head sizes have been cleared on R3 XLPE 36mm XLPE Liners via K092386, R3 40 and 44mm XLPE Liners via K093363, and REFLECTION 32mm X 50-52mm XLPE Acetabular Liner via K002747. Indications for Use Hip components are indicated for individuals undergoing primary and revision surgery where other treatme… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 36 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 13 of the 47 ancestors have a recall of any class.
- 4 other devices also cite its predicate K113848.
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. 2022, 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 for…
Read the full statement (133 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 R3 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/K211330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211330: R3 Large Head Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211330
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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