510(k) · Cleared
ClearedOXINIUM DH Fermoral Heads
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 Dec 14, 2016 as substantially equivalent to K093363 (Smith & Nephew, Inc., 2010) and 2 other predicates after a 226-day review. Its family tree reaches back 5 generations to 1996. 6 later devices descend from it.
- Decided
- Dec 14, 2016
- Review
- 226 days
- Class
- Class II
- Product code
- MBL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K955033 (1996). 47 ancestors in all, the oldest K861766 (1986). 6 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 4 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 3 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 2 generations backK022958 Total Hip Femoral Heads and LinersSmith & Nephew, Inc. · 2002 · Recalled
- 1 generation backK081566 Smith & Nephew Oxinium DH Femoral HeadsSmith & Nephew, Inc. · 2008
- This deviceK161233 OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK191002 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK220959 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK232667 OR3O Dual Mobility LinersSmith & Nephew, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK253948 Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK243456 ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191002OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019 · cites it directly5descendants
- K220959OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2022 · 2 generations on3descendants
- K232667OR3O Dual Mobility LinersSmith & Nephew, Inc. · 2023 · 2 generations on1descendant
- K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026 · 3 generations on0descendants
- K243456ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −4 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −3 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −2 | K022958 | Total Hip Femoral Heads and Liners | Smith & Nephew, Inc. | 2002 | 1 |
| −1 | K081566 | Smith & Nephew Oxinium DH Femoral Heads | Smith & Nephew, Inc. | 2008 | — |
| 0 (this device) | K161233 | OXINIUM DH Fermoral Heads | Smith & Nephew, Inc. | 2016 | — |
| +1 | K191002 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2019 | — |
| +2 | K220959 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2022 | — |
| +2 | K232667 | OR3O Dual Mobility Liners | Smith & Nephew, Inc. | 2023 | — |
| +3 | K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026 | — |
| +2 | K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 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 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (3)
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 |
|---|---|---|---|
| * | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSummary page 4…joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (CFR 888.3353), LZO III. PREDICATE DEVICE K093363 (S.E. 01/26/2010) COCR and OXINIUM Femoral Heads – Primary Predicate K08156… | 2010 |
| * | K081566 | Smith & Nephew Oxinium DH Femoral HeadsSummary page 4…3353), LZO III. PREDICATE DEVICE K093363 (S.E. 01/26/2010) COCR and OXINIUM Femoral Heads – Primary Predicate K081566 (S.E. 08/21/2008) OXINIUM DH Femoral Heads – Predicate 2 K021673 (S.E. 06/1… | 2008 |
| * | K021673 | Total Hip Femoral Head - 12/14 TaperSummary page 4…– Primary Predicate K081566 (S.E. 08/21/2008) OXINIUM DH Femoral Heads – Predicate 2 K021673 (S.E. 06/11/2002) TOTAL HIP Femoral Head-12/14 Taper – Predicate 3 Th… | 2002 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191002 | OR3O Dual Mobility System | 2019 | 5 |
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 20 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 13 of the 47 ancestors have a recall of any class.
- Of its descendants, K191002 (Smith & Nephew, Inc., 2019) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K093363.
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. 2016, 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 (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 (145 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.
Total hip systems may be indicated for use (i) with bone cement , (ii) without bone cement , or (iii) for use with or without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161233 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161233: OXINIUM DH Fermoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161233
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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