510(k) · Cleared
ClearedExactech® Novation® Element Press-fit Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Aug 31, 2016 as substantially equivalent to K080980 (Exactech, Inc., 2008) after a 254-day review. Its family tree reaches back 6 generations to 1994. 5 later devices descend from it.
- Decided
- Aug 31, 2016
- Review
- 254 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931641 (1994). 18 ancestors in all, the oldest K862234 (1986). 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 4 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 3 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 2 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 1 generation backK080980 Exactech Novation Element Press-Fit Femoral StemsExactech, Inc. · 2008 · Recalled
- This deviceK153649 Exactech® Novation® Element Press-fit Femoral StemExactech, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK171249 Entrada™ hip stemOrtho Development Corporation · 2017
- Descendant · 2 generations on · 1 of its ownK233758 Trivicta™ Hip StemOrtho Development Corp. · 2024
- Descendant · cites it directly · 1 of its ownK162732 Exactech® Alteon® HA Femoral StemExactech, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK251052 Trivicta® Hip StemOrtho Development Corp. · 2025
- Descendant · 2 generations on · 0 of its ownK243839 Alteon® HA Femoral StemsExactech, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K171249Entrada™ hip stemOrtho Development Corporation · 2017 · cites it directly2descendants
- K233758Trivicta™ Hip StemOrtho Development Corp. · 2024 · 2 generations on1descendant
- K162732Exactech® Alteon® HA Femoral StemExactech, Inc. · 2017 · cites it directly1descendant
- K251052Trivicta® Hip StemOrtho Development Corp. · 2025 · 3 generations on0descendants
- K243839Alteon® HA Femoral StemsExactech, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −5 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −4 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −3 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −2 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −1 | K080980 | Exactech Novation Element Press-Fit Femoral Stems | Exactech, Inc. | 2008 | 1 |
| 0 (this device) | K153649 | Exactech® Novation® Element Press-fit Femoral Stem | Exactech, Inc. | 2016 | — |
| +1 | K171249 | Entrada™ hip stem | Ortho Development Corporation | 2017 | — |
| +2 | K233758 | Trivicta™ Hip Stem | Ortho Development Corp. | 2024 | — |
| +1 | K162732 | Exactech® Alteon® HA Femoral Stem | Exactech, Inc. | 2017 | 1 |
| +3 | K251052 | Trivicta® Hip Stem | Ortho Development Corp. | 2025 | — |
| +2 | K243839 | Alteon® HA Femoral Stems | Exactech, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K080980 | Exactech Novation Element Press-Fit Femoral StemsSummary page 4…888.3353, Class II, Product Code MEH Legally Marketed Device to Which Substantial Equivalence Is Claimed: • Exactech Novation Element Press-Fit Femoral Stem (K080980) Device Description The Novation Element Press-Fit Femoral Stem is manufactured from Ti-6Al-4V with a grit blast surface and HA… | 2008 |
What descends from it? (5)
2 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K171249 (Ortho Development Corporation, 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K080980.
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. 2016, 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?
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing…
Read the full statement (97 words)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
• Novation Element press-fit femoral stems with HA coating are intended for press-fit fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153649: Exactech® Novation® Element Press-fit Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153649
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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