510(k) · Cleared
Recalled · Class II · 2022Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Nov 19, 1999 as substantially equivalent to K921114 (Exactech, Inc., 1993) and 3 other predicates after a 65-day review. Its family tree reaches back 1 generation to 1993. 161 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 19, 1999
- Review
- 65 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 1 generation to K921114 (1993). 4 ancestors in all. 161 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK921114 Exactech MCS Porous Coated Total Hip AcetabularExactech, Inc. · 1993
- This deviceK993082 Exactech Acumatch Integrated Hip System a-Series Porous Coated…Exactech, Inc. · 1999
- Descendant · cites it directly · 145 of its ownK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 64 of its ownK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- Descendant · cites it directly · 61 of its ownK040613 Exactech Acumatch a-Series and MCS Acetabular Shells and LinersExactech, Inc. · 2004 · Recalled
- Descendant · cites it directly · 60 of its ownK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- Descendant · cites it directly · 59 of its ownK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
Showing 5 of 161 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 161 · See all- K041906Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · cites it directly145descendants
- K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004 · 2 generations on64descendants
- K040613Exactech Acumatch a-Series and MCS Acetabular Shells and LinersExactech, Inc. · 2004 · cites it directly61descendants
- K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · cites it directly60descendants
- K070479Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · cites it directly59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921114 | Exactech MCS Porous Coated Total Hip Acetabular | Exactech, Inc. | 1993 | — |
| 0 (this device) | K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular… | Exactech, Inc. | 1999 | — |
| +1 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| +2 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| +1 | K040613 | Exactech Acumatch a-Series and MCS Acetabular Shells and Liners | Exactech, Inc. | 2004 | 1 |
| +1 | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | 12 |
| +1 | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | 16 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 8 | 0 |
| 2019 | 14 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 11 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 17 | 0 |
| 2026 | 14 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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 |
|---|---|---|---|
| * | K921114 | Exactech MCS Porous Coated Total Hip AcetabularSummary page 1…ries is equivalent in materials and design to the Exactech MCS Porous Cup and Exactech MCS/HA Porous Cup: Product Code Model Manufacturer 510(k) Number LPH MCS Exactech K921114 LPH MCS/HA Exactech K990197 Additionally, the A-Series System is of a similar design to other acetabular components on the marke… | 1993 |
| * | K990197 | Modulus Compatible Stability (MCS)-HA Total Hip SystemSummary page 1…als and design to the Exactech MCS Porous Cup and Exactech MCS/HA Porous Cup: Product Code Model Manufacturer 510(k) Number LPH MCS Exactech K921114 LPH MCS/HA Exactech K990197 Additionally, the A-Series System is of a similar design to other acetabular components on the market: Product Code Model Manuf… | 1999 |
| * | K932755 | Reflection Acetabular ComponentSummary page 1…y, the A-Series System is of a similar design to other acetabular components on the market: Product Code Model Manufacturer 510(k) Number LPH Reflection Smith & Nephew K932755 LPH Omnifit Osteonics ~ ------- LPH Trilogy Zimmer K934765 Section 4 Page 2 of 6 Exactech® AcuMatch™ Integrated… | 1994 |
| * | K934765 | Trilogy Acetabular SystemSummary page 1…abular components on the market: Product Code Model Manufacturer 510(k) Number LPH Reflection Smith & Nephew K932755 LPH Omnifit Osteonics ~ ------- LPH Trilogy Zimmer K934765 Section 4 Page 2 of 6 Exactech® AcuMatch™ Integrated Hip System A-Series Porous Coated Acetabular Component 510… | 1994 |
| * | — | Omnifit Named without a submission number | |
| * | — | Inter-Op Named without a submission number |
What descends from it? (161)
See all 1619 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041906 | Exactech 12/14 Total Hip System | 2004 | 145 |
| K040613 | Exactech Acumatch a-Series and MCS Acetabular Shells and Liners | 2004 | 61 |
| K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | 2005 | 60 |
| K070479 | Exactech Novation Crown Cup and Liners | 2007 | 59 |
| K141797 | Alteon 6.5MM Bone Screws | 2014 | 6 |
| K103352 | Versafitcup CC Trio | 2011 | 4 |
| K182502 | Alteon Acetabular Cup System | 2019 | 2 |
| K094045 | Modificaiton to: Cardo Medical Hip System | 2010 | 1 |
| K040601 | Exactech Acumatch a-Series & MCS Constrained Acetabular Liners | 2004 | 1 |
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-1734-2022 | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| Nov 7, 2016 | Class II | Z-1031-2017 | Under Investigation by firm | Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
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 (102 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 A-Series Porous Coated Acetabular Components are intended to be used
in press fit and cemented applications.
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/K993082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993082: Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993082
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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