510(k) · Cleared
Recalled · Class II · 2022Exactech Acumatch a-Series and MCS Acetabular Shells and Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Jun 4, 2004 as substantially equivalent to K993082 (Exactech, Inc., 1999) and 3 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1993. 61 later devices descend from it. It has been recalled once.
- Decided
- Jun 4, 2004
- Review
- 87 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K921114 (1993). 6 ancestors in all. 61 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK921114 Exactech MCS Porous Coated Total Hip AcetabularExactech, Inc. · 1993
- 1 generation backK993082 Exactech Acumatch Integrated Hip System a-Series Porous Coated…Exactech, Inc. · 1999 · Recalled
- This deviceK040613 Exactech Acumatch a-Series and MCS Acetabular Shells and LinersExactech, Inc. · 2004
- Descendant · cites it directly · 60 of its ownK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 59 of its ownK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 53 of its ownK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
- Descendant · 4 generations on · 36 of its ownK122798 Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc. · 2012
- Descendant · 4 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · cites it directly60descendants
- K070479Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · 2 generations on59descendants
- K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010 · 3 generations on53descendants
- K122798Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc. · 2012 · 4 generations on36descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 4 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921114 | Exactech MCS Porous Coated Total Hip Acetabular | Exactech, Inc. | 1993 | — |
| −1 | K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular… | Exactech, Inc. | 1999 | 2 |
| 0 (this device) | K040613 | Exactech Acumatch a-Series and MCS Acetabular Shells and Liners | Exactech, Inc. | 2004 | — |
| +1 | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | 12 |
| +2 | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | 16 |
| +3 | K102975 | Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole | Exactech, Inc. | 2010 | — |
| +4 | K122798 | Integrip Acetabular Shell, Integrip Revision Acetabular Shell | Exactech, Inc. | 2012 | — |
| +4 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 8 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 8 | 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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 |
|---|---|---|---|
| * | K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentSummary page 2…d to restore mobility resulting from previous fusion. Substantial Equivalence: The devices are line extensions, identical to previously cleared Exactech AcuMatch® (K993082 & K000242) and MCS® (K921114 & K990197) Shells and Liners.… | 1999 |
| * | K000242 | Acumatch a-Series Corundum Acetabular Component and Acumatch a-Series Corundum…Summary page 2…re mobility resulting from previous fusion. Substantial Equivalence: The devices are line extensions, identical to previously cleared Exactech AcuMatch® (K993082 & K000242) and MCS® (K921114 & K990197) Shells and Liners.… | 2000 |
| * | K921114 | Exactech MCS Porous Coated Total Hip AcetabularSummary page 2…ng from previous fusion. Substantial Equivalence: The devices are line extensions, identical to previously cleared Exactech AcuMatch® (K993082 & K000242) and MCS® (K921114 & K990197) Shells and Liners. 11… | 1993 |
| * | K990197 | Modulus Compatible Stability (MCS)-HA Total Hip SystemSummary page 2…vious fusion. Substantial Equivalence: The devices are line extensions, identical to previously cleared Exactech AcuMatch® (K993082 & K000242) and MCS® (K921114 & K990197) Shells and Liners. 11 Premarket N… | 1999 |
What descends from it? (61)
See all 611 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | 2005 | 60 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2022 | Class II | Z-1726-2022 | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 6.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K051556 (Exactech, Inc., 2005) has gone furthest, with 60 descendants of its own.
- 8 other devices also cite its predicate K993082.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, 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 ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040613: Exactech Acumatch a-Series and MCS Acetabular Shells and Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040613
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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