510(k) · Cleared
ClearedAcumatch L-Series Unipolar Endoprosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Feb 5, 2001 as substantially equivalent to K960538 (Exactech, Inc., 1996) after a 26-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.
- Decided
- Feb 5, 2001
- Review
- 26 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881288 (1988). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK881288 Corin Modular Moore StemOrthopedic Systems, Inc. · 1988
- 1 generation backK960538 Opteon UnipolarExactech, Inc. · 1996
- This deviceK010081 Acumatch L-Series Unipolar EndoprosthesisExactech, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK021109 Esop CO-CR Femoral HeadsFournitures Hospitalieres · 2002
- Descendant · 2 generations on · 0 of its ownK050556 Alumina HeadFournitures Hospitalieres Industrie · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881288 | Corin Modular Moore Stem | Orthopedic Systems, Inc. | 1988 | — |
| −1 | K960538 | Opteon Unipolar | Exactech, Inc. | 1996 | — |
| 0 (this device) | K010081 | Acumatch L-Series Unipolar Endoprosthesis | Exactech, Inc. | 2001 | — |
| +1 | K021109 | Esop CO-CR Femoral Heads | Fournitures Hospitalieres | 2002 | — |
| +2 | K050556 | Alumina Head | Fournitures Hospitalieres Industrie | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 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 KWY? 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 KWY device
- #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · 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 |
|---|---|---|---|
| * | K960538 | Opteon UnipolarSummary page 2…Exactech Opteon Endoprosthesis: Model Opteon Unipolar Endoprosthesis Unitrax Unipolar System Unipolar System Bio-Moore 11 Manufacturer 510(k) Number Exactech, Inc. K960538 Howmedica e Smith & Nephew = -----vmemm- BioMet =00 ceeemeeeee- The proposed AcuMatch L-Series Unipolar Endoprosthesis has the s… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021109 | Esop CO-CR Femoral Heads | 2002 | 1 |
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 13 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K021109 (Fournitures Hospitalieres, 2002) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K960538.
How does its category compare?
All KWY devicesKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWY
126in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWY
180in 2025
MAUDE reports naming product code KWY, 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 | 0 | — | 25 | 370 |
| 2008 | 3 | 123 | 0 | 900 |
| 2009 | 1 | — | 24 | 961 |
| 2010 | 4 | 187 | 1 | 688 |
| 2011 | 1 | — | 0 | 758 |
| 2012 | 1 | — | 1 | 978 |
| 2013 | 2 | — | 2 | 1,148 |
| 2014 | 1 | — | 0 | 1,055 |
| 2015 | 1 | — | 0 | 1,213 |
| 2016 | 1 | — | 3 | 877 |
| 2017 | 1 | — | 2 | 826 |
| 2018 | 3 | 219 | 1 | 1,380 |
| 2019 | 5 | 126 | 1 | 1,530 |
| 2020 | 1 | — | 0 | 1,259 |
| 2021 | 0 | — | 0 | 276 |
| 2022 | 2 | — | 0 | 208 |
| 2023 | 2 | — | 0 | 178 |
| 2024 | 0 | — | 1 | 209 |
| 2025 | 1 | — | 2 | 180 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The AcuMatch L-Series Unipolar Endoprosthesis is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for use in replacement of the femoral head following femoral neck fracture. The AcuMatch L-Series Unipolar Endoprosthesis is contraindicated in patients with active infection, patients…
Read the full statement (124 words)
The AcuMatch L-Series Unipolar Endoprosthesis is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for use in replacement of the femoral head following femoral neck fracture.
The AcuMatch L-Series Unipolar Endoprosthesis is contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system. The L-Series Unipolar is also contraindicated for use in patients with evidence of degenerative changes in the acetabulum and/or pelvic fractures.
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/K010081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010081: Acumatch L-Series Unipolar Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010081
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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