510(k) · Cleared
ClearedAcumatch L-Series Cemented Femoral Stem, Model L-Series Cemented
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 May 18, 2000 as substantially equivalent to K961304 (Exactech, Inc., 1996) after a 21-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.
- Decided
- May 18, 2000
- Review
- 21 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961304 (1996). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK961304 Aura Hip System Cemented Femoral Stem/Cemented Long Femoral StemExactech, Inc. · 1996
- This deviceK001335 Acumatch L-Series Cemented Femoral Stem, Model L-Series CementedExactech, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK052787 Acumatch 12/14 C-Series Cemented Femoral Stems (Size 1-6), Acumatch…Exactech, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK083392 Novation 12/14 Cemented Femoral StemsExactech, Inc. · 2008 · Recalled
- Descendant · 3 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 4 of 4 · See all- K052787Acumatch 12/14 C-Series Cemented Femoral Stems (Size 1-6), Acumatch 12/14 L-Series…Exactech, Inc. · 2005 · cites it directly2descendants
- K083392Novation 12/14 Cemented Femoral StemsExactech, Inc. · 2008 · 2 generations on1descendant
- K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc. · 2009 · 3 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 |
|---|---|---|---|---|---|
| −1 | K961304 | Aura Hip System Cemented Femoral Stem/Cemented Long Femoral Stem | Exactech, Inc. | 1996 | — |
| 0 (this device) | K001335 | Acumatch L-Series Cemented Femoral Stem, Model L-Series Cemented | Exactech, Inc. | 2000 | — |
| +1 | K052787 | Acumatch 12/14 C-Series Cemented Femoral Stems (Size 1-6), Acumatch 12/14… | Exactech, Inc. | 2005 | — |
| +2 | K083392 | Novation 12/14 Cemented Femoral Stems | Exactech, Inc. | 2008 | 1 |
| +3 | 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 |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K961304 | Aura Hip System Cemented Femoral Stem/Cemented Long Femoral StemSummary page 1…ip, Semi-Constrained, Metal/Polymer, Cemented, (Femoral Component) Legally Marketed Devices for Substantial Equivalence Comparison: Model Manufacturer AuRA Exactech (#K961304) Conquest FX Smith & Nephew Spectron Smith & Nephew PFC Depuy Substantial Equivalence Information: The Exactech AcuMatch L-Seri… | 1996 |
| * | — | Conquest FX Named without a submission number | |
| * | — | Spectron Named without a submission number | |
| * | — | PFC Named without a submission number |
What descends from it? (4)
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?
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?
AcuMatch L-Series Cemented Femoral Stem Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, 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.…
Read the full statement (100 words)
AcuMatch L-Series Cemented Femoral Stem Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, 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 revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.
AcuMatch L-Series Cemented Femoral Stem Components are intended to be used with bone cement.
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/K001335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001335: Acumatch L-Series Cemented Femoral Stem, Model L-Series Cemented.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001335
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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