510(k) · Cleared
ClearedEchelon Porous Plus HA Hip Stems
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 Oct 25, 2002 as substantially equivalent to K002996 (Smith & Nephew, Inc., 2000) and 1 other predicate after a 22-day review. Its family tree reaches back 1 generation to 1998. 25 later devices descend from it.
- Decided
- Oct 25, 2002
- Review
- 22 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971206 (1998). 2 ancestors in all. 25 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK971206 Meridian ST Femoral Stem and Vitalock Solid Back Shell W/…Howmedica Corp. · 1998 · Recalled
- This deviceK023302 Echelon Porous Plus HA Hip StemsSmith & Nephew, Inc. · 2002
- Descendant · cites it directly · 19 of its ownK032683 Genesis II Porous Plus HA Knee SystemSmith & Nephew, Inc. · 2003
- Descendant · 2 generations on · 12 of its ownK100897 Legion Porous + HA Tibial BaseplatesSmith & Nephew, Inc. · 2010
- Descendant · 3 generations on · 5 of its ownK211221 Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc. · 2021
- Descendant · 2 generations on · 5 of its ownK190577 World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd. · 2019
- Descendant · 2 generations on · 5 of its ownK121393 Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K032683Genesis II Porous Plus HA Knee SystemSmith & Nephew, Inc. · 2003 · cites it directly19descendants
- K100897Legion Porous + HA Tibial BaseplatesSmith & Nephew, Inc. · 2010 · 2 generations on12descendants
- K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc. · 2021 · 3 generations on5descendants
- K190577World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd. · 2019 · 2 generations on5descendants
- K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971206 | Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating | Howmedica Corp. | 1998 | 1 |
| 0 (this device) | K023302 | Echelon Porous Plus HA Hip Stems | Smith & Nephew, Inc. | 2002 | — |
| +1 | K032683 | Genesis II Porous Plus HA Knee System | Smith & Nephew, Inc. | 2003 | — |
| +2 | K100897 | Legion Porous + HA Tibial Baseplates | Smith & Nephew, Inc. | 2010 | — |
| +3 | K211221 | Porous Patella and Porous Tibia Baseplate | Smith & Nephew, Inc. | 2021 | — |
| +2 | K190577 | World Knee Total Knee Systems | Signature Orthopaedics Pty, Ltd. | 2019 | — |
| +2 | K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | Smith & Nephew, Inc. | 2012 | 4 |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K002996 | Synergy HA Coated Porous Femoral StemsSummary page 1…ss II Substantially Equivalent LegaUy Marketed Devices Echelon Porous Plus HA Hip Stems are substantidly equivalent to Smith & Nephew Synergy KA on Porous Hip Sterns 0(002996), Howmedica Meridian STPA Femoral Stems (K97 1206) and Osteoimplant Technology,Inc. LSF HA Coated Triad Total Hip System (fixnod… | 2000 |
| * | K971206 | Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite CoatingSummary page 1…Devices Echelon Porous Plus HA Hip Stems are substantidly equivalent to Smith & Nephew Synergy KA on Porous Hip Sterns 0(002996), Howmedica Meridian STPA Femoral Stems (K97 1206) and Osteoimplant Technology,Inc. LSF HA Coated Triad Total Hip System (fixnod stems). Device Description Echelon Porous Plus HA… | 1998 |
| * | — | Osteoimplant Technology, Inc. LSF HA Coated Triad Total Hip System (fixnod stems) Named without a submission number |
What descends from it? (25)
See all 253 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.
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 componmts are indicated for uncemented use only in 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 (N1DID)or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused…
Read the full statement (126 words)
Total hip componmts are indicated for uncemented use only in 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 (N1DID)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 dminase-fiee period; non-union; femoral neck fracture and trochanteric fractures of the proximal femurwith head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Echelob Porous Plus H A Hip Stem components are intended uncemented use for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023302: Echelon Porous Plus HA Hip Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023302
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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