510(k) · Cleared
ClearedSmith & Nephew Oxinium DH Femoral Heads
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 Aug 21, 2008 as substantially equivalent to K021673 (Smith & Nephew, Inc., 2002) and 1 other predicate after a 78-day review. Its family tree reaches back 4 generations to 1996. 8 later devices descend from it.
- Decided
- Aug 21, 2008
- Review
- 78 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K955033 (1996). 8 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 3 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 2 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 1 generation backK022958 Total Hip Femoral Heads and LinersSmith & Nephew, Inc. · 2002 · Recalled
- This deviceK081566 Smith & Nephew Oxinium DH Femoral HeadsSmith & Nephew, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK161233 OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK191002 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019
- Descendant · 3 generations on · 3 of its ownK220959 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK232667 OR3O Dual Mobility LinersSmith & Nephew, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK253948 Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016 · cites it directly6descendants
- K191002OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019 · 2 generations on5descendants
- K220959OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2022 · 3 generations on3descendants
- K232667OR3O Dual Mobility LinersSmith & Nephew, Inc. · 2023 · 3 generations on1descendant
- K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −3 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −2 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −1 | K022958 | Total Hip Femoral Heads and Liners | Smith & Nephew, Inc. | 2002 | 1 |
| 0 (this device) | K081566 | Smith & Nephew Oxinium DH Femoral Heads | Smith & Nephew, Inc. | 2008 | — |
| +1 | K161233 | OXINIUM DH Fermoral Heads | Smith & Nephew, Inc. | 2016 | — |
| +2 | K191002 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2019 | — |
| +3 | K220959 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2022 | — |
| +3 | K232667 | OR3O Dual Mobility Liners | Smith & Nephew, Inc. | 2023 | — |
| +4 | K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K021673 | Total Hip Femoral Head - 12/14 TaperSummary page 1…is provided in Tables 1and 2, respectively. The overall design of the Oxinium DH femoral heads is based upon the existing Total Hip 12/14 Taper Femora[ Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners. Table 1: Previously cleared Smith… | 2002 |
| * | K022958 | Total Hip Femoral Heads and LinersSummary page 1…esign of the Oxinium DH femoral heads is based upon the existing Total Hip 12/14 Taper Femora[ Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners. Table 1: Previously cleared Smith & Nephew hip stems with a 12/14 taper Description… | 2002 |
What descends from it? (8)
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 12 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K161233 (Smith & Nephew, Inc., 2016) has gone furthest, with 6 descendants of its own.
- 7 other devices also cite its predicate K021673.
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. 2008, 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?
Total 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, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the…
Read the full statement (119 words)
Total 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, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Oxinium DH femoral heads are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081566: Smith & Nephew Oxinium DH Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081566
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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