510(k) · Cleared
ClearedSmith & Nephew Hip Systems with HA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Apr 21, 2010 as substantially equivalent to K052792 (Smith & Nephew, Inc., 2005) and 4 other predicates after a 379-day review. Its family tree reaches back 1 generation to 1997. 24 later devices descend from it.
- Decided
- Apr 21, 2010
- Review
- 379 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K970337 (1997). 5 ancestors in all. 24 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK970337 HA Global Taper (GT) Tapered Hip StemSmith & Nephew, Inc., Orthopaedic Div. · 1997
- This deviceK090982 Smith & Nephew Hip Systems with HASmith & Nephew, Inc. · 2010
- Descendant · cites it directly · 22 of its ownK101072 Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium…Howmedica Osteonics Corp. · 2011
- Descendant · 2 generations on · 21 of its ownK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- Descendant · 3 generations on · 20 of its ownK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- Descendant · 4 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- Descendant · 5 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp. · 2011 · cites it directly22descendants
- K122158PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012 · 2 generations on21descendants
- K131237Pipeline Total Hip SystemPipeline Orthopedics · 2013 · 3 generations on20descendants
- K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · 4 generations on19descendants
- K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970337 | HA Global Taper (GT) Tapered Hip Stem | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| 0 (this device) | K090982 | Smith & Nephew Hip Systems with HA | Smith & Nephew, Inc. | 2010 | — |
| +1 | K101072 | Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite | Howmedica Osteonics Corp. | 2011 | — |
| +2 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| +3 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| +4 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| +5 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2026 | 5 | 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K052792 | Anthology Hip StemSummary page 1…tems * Porous Anthology Hip Stems • Porous Reflection Acetabular Shells The Smith & Nephew Hip Stems with HA coating have been cleared for market by FDA via K052792, K(002996 and K(970337. The Reflection Acetabular cups with HA coating have been cleared for market by FDA via K(990666 and 1(022… | 2005 |
| * | K002996 | Synergy HA Coated Porous Femoral StemsSummary page 2…Hip Systems with HA are similar inoverall design, material and indications to the Smith & Nephew Hip Systems with HA cleared via 510(k) Premarket Notifications K052792, K002996, K970337, K990666, and K(022556. Summary of Safety and Effectiveness… | 2000 |
| * | K970337 | HA Global Taper (GT) Tapered Hip StemSummary page 2…ems with HA are similar inoverall design, material and indications to the Smith & Nephew Hip Systems with HA cleared via 510(k) Premarket Notifications K052792, K002996, K970337, K990666, and K(022556. Summary of Safety and Effectiveness… | 1997 |
| * | K990666 | Hydroxyapatite (HA) Reflection Acetabular Shell, Hydroxyapatite (HA) Reflection Interfit…Summary page 2…HA are similar inoverall design, material and indications to the Smith & Nephew Hip Systems with HA cleared via 510(k) Premarket Notifications K052792, K002996, K970337, K990666, and K(022556. Summary of Safety and Effectiveness Page 2of… | 1999 |
| * | K022556 | Reflection Modified Acetabular ShellsSummary page 1…been cleared for market by FDA via K052792, K(002996 and K(970337. The Reflection Acetabular cups with HA coating have been cleared for market by FDA via K(990666 and 1(022556. The design, principle of operation, type of substrate materials, dimensional characteristics and indications for use will not ch… | 2002 |
What descends from it? (24)
See all 242 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?
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
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 (122 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; 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 Hip System components with HA are intended for single use only and are intended to be implanted without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090982: Smith & Nephew Hip Systems with HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090982
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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