PMA · Approved
Recalled · Class II · 2016Novation Ceramic Articulation Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Approved on Jul 5, 2007 through premarket approval, which rests on the device’s own clinical evidence after a 616-day review. It has been recalled 6 times.
- Decided
- Jul 5, 2007
- Review
- 616 days
- Class
- Class III
- Product code
- MRA
- Recalls
- 6
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P050039 has 20 supplements since 2008: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 8 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 12, 2016 | Class II | Z-1901-2016 | Packaging process control | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. |
| Apr 12, 2016 | Class II | Z-1905-2016 | Packaging process control | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. |
| Apr 12, 2016 | Class II | Z-1903-2016 | Packaging process control | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. |
| Apr 12, 2016 | Class II | Z-1900-2016 | Packaging process control | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. |
| Apr 12, 2016 | Class II | Z-1904-2016 | Packaging process control | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. |
| Apr 12, 2016 | Class II | Z-1902-2016 | Packaging process control | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MRA devicesMRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MRA
18in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRA
Too few MRA 510(k)s in any year since 2007 to give a median.
Recalls per year · MRA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRA
88in 2025
MAUDE reports naming product code MRA, 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 | 10 | — | 0 | 117 |
| 2008 | 12 | — | 5 | 146 |
| 2009 | 14 | — | 1 | 91 |
| 2010 | 14 | — | 0 | 188 |
| 2011 | 12 | — | 6 | 248 |
| 2012 | 28 | — | 2 | 283 |
| 2013 | 17 | — | 1 | 235 |
| 2014 | 9 | — | 0 | 281 |
| 2015 | 18 | — | 0 | 330 |
| 2016 | 26 | — | 0 | 367 |
| 2017 | 16 | — | 0 | 540 |
| 2018 | 11 | — | 0 | 696 |
| 2019 | 17 | — | 0 | 641 |
| 2020 | 13 | — | 0 | 371 |
| 2021 | 18 | — | 0 | 109 |
| 2022 | 33 | — | 0 | 89 |
| 2023 | 19 | — | 0 | 132 |
| 2024 | 16 | — | 0 | 118 |
| 2025 | 18 | — | 0 | 88 |
| 2026 | 7 | — | 0 | — |
https://510kreport.com/device/P050039 · printed Nov 6, 2026
Cite this page
510(k) Report. “P050039: Novation Ceramic Articulation Hip System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P050039
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026