510(k) · Cleared
ClearedAcumatch C-Series Cemented Femoral Component, Model Size 0
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 Aug 29, 2001 as substantially equivalent to K001335 (Exactech, Inc., 2000) and 2 other predicates after a 26-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Aug 29, 2001
- Review
- 26 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K961304 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK961304 Aura Hip System Cemented Femoral Stem/Cemented Long Femoral StemExactech, Inc. · 1996
- 1 generation backK001335 Acumatch L-Series Cemented Femoral Stem, Model L-Series CementedExactech, Inc. · 2000
- This deviceK012493 Acumatch C-Series Cemented Femoral Component, Model Size 0Exactech, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K012493 | Acumatch C-Series Cemented Femoral Component, Model Size 0 | Exactech, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (6)
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 |
|---|---|---|---|
| * | K001335 | Acumatch L-Series Cemented Femoral Stem, Model L-Series CementedSummary page 2…(Femoral Component) JDI 888.3350 1 Classification Panel: Orthopedic 510(K) Information — Predicate Devices Model Manufacturer 510(k)# AcuMatch L-Series Exactech #K001335, #K011218 AuRA Exactech #K961304 Conquest FX Smith & Nephew | Spectron Smith & Nephew PFC Depuy Substantial Equivalence Infor… | 2000 |
| * | K011218 | Acumatch L-Series Cemented Femoral Stem, Model Size 1Summary page 2…Component) JDI 888.3350 1 Classification Panel: Orthopedic 510(K) Information — Predicate Devices Model Manufacturer 510(k)# AcuMatch L-Series Exactech #K001335, #K011218 AuRA Exactech #K961304 Conquest FX Smith & Nephew | Spectron Smith & Nephew PFC Depuy Substantial Equivalence Information: T… | 2001 |
| * | K961304 | Aura Hip System Cemented Femoral Stem/Cemented Long Femoral StemSummary page 2…0 1 Classification Panel: Orthopedic 510(K) Information — Predicate Devices Model Manufacturer 510(k)# AcuMatch L-Series Exactech #K001335, #K011218 AuRA Exactech #K961304 Conquest FX Smith & Nephew | Spectron Smith & Nephew PFC Depuy Substantial Equivalence Information: The Exactech AcuMatch C-… | 1996 |
| * | — | Conquest FX Named without a submission number | |
| * | — | Spectron Named without a submission number | |
| * | — | PFC Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 1 company; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K001335.
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?
All Exactech Hip Systems 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…
Read the full statement (97 words)
All Exactech Hip Systems 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.
The AcuMatch C-Series Femoral component is 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/K012493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012493: Acumatch C-Series Cemented Femoral Component, Model Size 0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012493
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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