510(k) · Cleared
Recalled · Class II · 2015Exactech Novation Element Press-Fit Femoral Stems
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 May 6, 2008 as substantially equivalent to K990197 (Exactech, Inc., 1999) and 1 other predicate after a 29-day review. Its family tree reaches back 5 generations to 1994. 28 later devices descend from it. It has been recalled once.
- Decided
- May 6, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K931641 (1994). 17 ancestors in all, the oldest K862234 (1986). 28 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 4 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 3 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 2 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 1 generation backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- This deviceK080980 Exactech Novation Element Press-Fit Femoral StemsExactech, Inc. · 2008
- Descendant · cites it directly · 20 of its ownK121297 Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell…Signature Orthopaedics Pty, Ltd. · 2012 · Recalled
- Descendant · cites it directly · 5 of its ownK153649 Exactech® Novation® Element Press-fit Femoral StemExactech, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK133370 Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve…Signature Orthopaedics Pty Limited · 2014
- Descendant · 2 generations on · 4 of its ownK192559 Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG · 2019
- Descendant · 2 generations on · 4 of its ownK153131 Logical C-Series Acetabular Shell, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd. · 2016
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd. · 2012 · cites it directly20descendants
- K153649Exactech® Novation® Element Press-fit Femoral StemExactech, Inc. · 2016 · cites it directly5descendants
- K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited · 2014 · 2 generations on5descendants
- K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG · 2019 · 2 generations on4descendants
- K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd. · 2016 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −4 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −3 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −2 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −1 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| 0 (this device) | K080980 | Exactech Novation Element Press-Fit Femoral Stems | Exactech, Inc. | 2008 | — |
| +1 | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal… | Signature Orthopaedics Pty, Ltd. | 2012 | 2 |
| +1 | K153649 | Exactech® Novation® Element Press-fit Femoral Stem | Exactech, Inc. | 2016 | — |
| +2 | K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip… | Signature Orthopaedics Pty Limited | 2014 | — |
| +2 | K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System) | Waldemar Link GmbH & Co. KG | 2019 | — |
| +2 | K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical… | Signature Orthopaedics Pty, Ltd. | 2016 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K990197 | Modulus Compatible Stability (MCS)-HA Total Hip SystemSummary page 2…rmation on devices to which substantial equivalence is claimed: 510(k) Trade or Proprietary or Model Name Manufacturer Number K990197 HA coated MCS Total Hip System Exactech, Inc. K041906 12/14 Acumatch Press… | 1999 |
| * | K041906 | Exactech 12/14 Total Hip SystemSummary page 2…ry or Model Name Manufacturer Number K990197 HA coated MCS Total Hip System Exactech, Inc. K041906 12/14 Acumatch Press-Fit Femoral Stem Exactech, Inc. DESCRIPTION OF DEVICE MODIFICATIONS… | 2004 |
What descends from it? (28)
See all 283 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2015 | Class II | Z-0201-2016 | Under Investigation by firm | Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K121297 (Signature Orthopaedics Pty, Ltd., 2012) has gone furthest, with 20 descendants of its own.
- 4 other devices also cite its predicate K990197.
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. 2008, 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 (96 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/K080980 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080980: Exactech Novation Element Press-Fit Femoral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080980
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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