510(k) · Cleared
Recalled · Class II · 2024Total Hip Femoral Head - 12/14 Taper
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jun 11, 2002 after a 21-day review. The FDA summary names no predicate by number. 15 later devices descend from it. It has been recalled once.
- Decided
- Jun 11, 2002
- Review
- 21 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 0
15 later devices descend from it, 8 citing it directly.
- This deviceK021673 Total Hip Femoral Head - 12/14 TaperSmith & Nephew, Inc. · 2002
- Descendant · cites it directly · 8 of its ownK081566 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 · cites it directly · 5 of its ownK110101 Taper Oxinium Femoral HeadSmith & Nephew, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK220959 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K081566Smith & Nephew Oxinium DH Femoral HeadsSmith & Nephew, Inc. · 2008 · cites it directly8descendants
- K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016 · cites it directly6descendants
- K191002OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019 · 2 generations on5descendants
- K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc. · 2011 · cites it directly5descendants
- K220959OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2022 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021673 | Total Hip Femoral Head - 12/14 Taper | Smith & Nephew, Inc. | 2002 | — |
| +1 | 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 | — |
| +1 | K110101 | Taper Oxinium Femoral Head | Smith & Nephew, Inc. | 2011 | — |
| +3 | K220959 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (15)
See all 158 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081566 | Smith & Nephew Oxinium DH Femoral Heads | 2008 | 8 |
| K161233 | OXINIUM DH Fermoral Heads | 2016 | 6 |
| K110101 | Taper Oxinium Femoral Head | 2011 | 5 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip… | 2024 | 0 |
| K123598 | Smith & Nephew, Inc. Hip System Instrumentation | 2013 | 0 |
| K101472 | Multifit Total Hip System | 2011 | 0 |
| K023375 | Modification to Esop CO-CR Femoral Heads | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2024 | Class II | Z-1901-2024 | Process control | Packaging contained the incorrect size of femoral head from what was displayed on the label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081566 (Smith & Nephew, Inc., 2008) has gone furthest, with 8 descendants of its own.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
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; hsed hip; fracture of the…
Read the full statement (107 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; hsed 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 heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021673: Total Hip Femoral Head - 12/14 Taper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021673
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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