510(k) · Cleared
ClearedAura Hip System Cemented Femoral Stem/Cemented Long Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Oct 1, 1996 after a 180-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Oct 1, 1996
- Review
- 180 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK961304 Aura Hip System Cemented Femoral Stem/Cemented Long Femoral StemExactech, Inc. · 1996
- Descendant · cites it directly · 4 of its ownK001335 Acumatch L-Series Cemented Femoral Stem, Model L-Series CementedExactech, Inc. · 2000
- Descendant · 2 generations on · 2 of its ownK052787 Acumatch 12/14 C-Series Cemented Femoral Stems (Size 1-6), Acumatch…Exactech, Inc. · 2005
- Descendant · 3 generations on · 1 of its ownK083392 Novation 12/14 Cemented Femoral StemsExactech, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 0 of its ownK090764 Novation CFS Press-Fit and Cemented StemsExactech, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK012493 Acumatch C-Series Cemented Femoral Component, Model Size 0Exactech, Inc. · 2001
Most influential descendants
Showing 5 of 5 · See all- K001335Acumatch L-Series Cemented Femoral Stem, Model L-Series CementedExactech, Inc. · 2000 · cites it directly4descendants
- K052787Acumatch 12/14 C-Series Cemented Femoral Stems (Size 1-6), Acumatch 12/14 L-Series…Exactech, Inc. · 2005 · 2 generations on2descendants
- K083392Novation 12/14 Cemented Femoral StemsExactech, Inc. · 2008 · 3 generations on1descendant
- K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc. · 2009 · 4 generations on0descendants
- K012493Acumatch C-Series Cemented Femoral Component, Model Size 0Exactech, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961304 | Aura Hip System Cemented Femoral Stem/Cemented Long Femoral Stem | Exactech, Inc. | 1996 | — |
| +1 | K001335 | Acumatch L-Series Cemented Femoral Stem, Model L-Series Cemented | Exactech, Inc. | 2000 | — |
| +2 | K052787 | Acumatch 12/14 C-Series Cemented Femoral Stems (Size 1-6), Acumatch 12/14… | Exactech, Inc. | 2005 | — |
| +3 | K083392 | Novation 12/14 Cemented Femoral Stems | Exactech, Inc. | 2008 | 1 |
| +4 | K090764 | Novation CFS Press-Fit and Cemented Stems | Exactech, Inc. | 2009 | — |
| +1 | K012493 | Acumatch C-Series Cemented Femoral Component, Model Size 0 | Exactech, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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 |
|---|---|---|---|
| * | — | Smith & Nephew Orthopaedics Spectron® Total Hip System Named without a submission number |
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?
- Of its descendants, K001335 (Exactech, Inc., 2000) has gone furthest, with 4 descendants of its own.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The AuRA™ Cemented Femoral Stem and Cemented Long Femoral Stem are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also potentially indicated for revision of failed previous reconstruction where sufficient bone stock is present.
FOR CEMENTED USE ONLY
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/K961304 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961304: Aura Hip System Cemented Femoral Stem/Cemented Long Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961304
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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