510(k) · Cleared
ClearedSmith & Nephew Hip System
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 Oct 2, 2002 as substantially equivalent to K993259 (Sulzer Orthopedics, Inc., 2000) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1996. 285 later devices descend from it.
- Decided
- Oct 2, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K955033 (1996). 4 ancestors in all. 285 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 2 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 1 generation backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- This deviceK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- Descendant · cites it directly · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- Descendant · cites it directly · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004
- Descendant · 3 generations on · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
- Descendant · 4 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
Showing 5 of 285 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 285 · See all- K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · cites it directly267descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · cites it directly198descendants
- K043079Bicontact Hip System with U-CapAesculap · 2004 · 2 generations on166descendants
- K093472Trinity Acetabular SystemCorin USA · 2010 · 3 generations on117descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 4 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −2 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −1 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| 0 (this device) | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| +1 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| +1 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +2 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| +3 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
| +4 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 16 | 0 |
| 2012 | 22 | 0 |
| 2013 | 21 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 10 | 0 |
| 2017 | 16 | 0 |
| 2018 | 17 | 0 |
| 2019 | 15 | 0 |
| 2020 | 16 | 0 |
| 2021 | 19 | 0 |
| 2022 | 19 | 0 |
| 2023 | 18 | 0 |
| 2024 | 14 | 0 |
| 2025 | 22 | 0 |
| 2026 | 19 | 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 |
|---|---|---|---|
| * | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSummary page 1…ising the Smith & Nephew Hip System are substantially equivalent to Sulzer Inter-Op Durasul Acetabular Liner Inserts and femoral heads that were cleared for market under K993259 and K002575. Device Description The Smith & Nephew Hip . System ” is comprised of cross-lin… | 2000 |
| * | K002575 | Inter-OP Durasul Acetabular Inserts (4MM)Summary page 1…ith & Nephew Hip System are substantially equivalent to Sulzer Inter-Op Durasul Acetabular Liner Inserts and femoral heads that were cleared for market under K993259 and K002575. Device Description The Smith & Nephew Hip . System ” is comprised of cross-linked UHMWPE a… | 2000 |
What descends from it? (285)
See all 2856 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040191 | Bicontact Hip Stem and Femoral Head | 2004 | 267 |
| K042344 | Excia Total Hip System | 2005 | 198 |
| K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | 2010 | 16 |
| K110101 | Taper Oxinium Femoral Head | 2011 | 5 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K123598 | Smith & Nephew, Inc. Hip System Instrumentation | 2013 | 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 6 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K040191 (Aesculap, 2004) has gone furthest, with 267 descendants of its own.
- 4 other devices also cite its predicate K993259.
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.
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 (120 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 and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; 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 Hip System components are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022902 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022902: Smith & Nephew Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022902
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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