510(k) · Cleared
ClearedSynergy HA Coated Porous Femoral 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 Dec 11, 2000 after a 77-day review. The FDA summary names its predicate without a number. 203 later devices descend from it.
- Decided
- Dec 11, 2000
- Review
- 77 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 0
203 later devices descend from it, 11 citing it directly.
- This deviceK002996 Synergy HA Coated Porous Femoral StemsSmith & Nephew, Inc. · 2000
- Descendant · cites it directly · 146 of its ownK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- Descendant · 2 generations on · 145 of its ownK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 64 of its ownK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- Descendant · 3 generations on · 60 of its ownK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 59 of its ownK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
Showing 5 of 203 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 203 · See all- K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003 · cites it directly146descendants
- K041906Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · 2 generations on145descendants
- K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004 · 3 generations on64descendants
- K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · 3 generations on60descendants
- K070479Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · 4 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002996 | Synergy HA Coated Porous Femoral Stems | Smith & Nephew, Inc. | 2000 | — |
| +1 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| +2 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| +3 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| +3 | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | 12 |
| +4 | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | 16 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 8 | 0 |
| 2011 | 2 | 0 |
| 2012 | 11 | 0 |
| 2013 | 11 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 14 | 0 |
| 2018 | 8 | 0 |
| 2019 | 16 | 0 |
| 2020 | 8 | 0 |
| 2021 | 8 | 0 |
| 2022 | 13 | 0 |
| 2023 | 16 | 0 |
| 2024 | 17 | 0 |
| 2025 | 14 | 0 |
| 2026 | 18 | 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 |
|---|---|---|---|
| * | — | Global Taper Tapered (Synergy) HA Hip Stem Named without a submission number | |
| * | — | Secur-Fit® HA Hip Stem Named without a submission number | |
| * | — | Omnifit® HA Hip Stem Named without a submission number | |
| * | — | Meridian® ST/PA Femoral Stem Named without a submission number | |
| * | — | APR Porous HA Hip System Named without a submission number |
What descends from it? (203)
See all 20311 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | 2003 | 146 |
| K023302 | Echelon Porous Plus HA Hip Stems | 2002 | 25 |
| K090982 | Smith & Nephew Hip Systems with HA | 2010 | 24 |
| K032683 | Genesis II Porous Plus HA Knee System | 2003 | 19 |
| K042127 | Smith & Nephew Modular Hip | 2004 | 17 |
| K061066 | Synergy Hip System | 2006 | 16 |
| K052426 | Smith & Nephew Modular Hip | 2005 | 6 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K052275 | Smith & Nephew Platform Hip Stem | 2005 | 1 |
| 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?
- Of its descendants, K030236 (Exactech, Inc., 2003) has gone furthest, with 146 descendants of its own.
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 components 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 non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused…
Read the full statement (111 words)
Total hip components 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 non-inflammatory 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; old, remote osteomyelitis with an extended drainage-free period; 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K002996 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002996: Synergy HA Coated Porous Femoral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002996
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026