510(k) · Cleared
Recalled · Class II · 2022Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene
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 Sep 6, 2005 as substantially equivalent to K993082 (Exactech, Inc., 1999) and 2 other predicates after an 85-day review. Its family tree reaches back 5 generations to 1994. 60 later devices descend from it. It has been recalled 12 times.
- Decided
- Sep 6, 2005
- Review
- 85 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 12
- Predicates
- 3
Its longest line of descent runs back 5 generations to K931641 (1994). 19 ancestors in all, the oldest K862234 (1986). 60 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 4 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 3 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 2 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 1 generation backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- This deviceK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005
- Descendant · cites it directly · 59 of its ownK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 53 of its ownK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
- Descendant · 3 generations on · 36 of its ownK122798 Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc. · 2012
- Descendant · 3 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- Descendant · 3 generations on · 12 of its ownK112898 Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K070479Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · cites it directly59descendants
- K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010 · 2 generations on53descendants
- K122798Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc. · 2012 · 3 generations on36descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 3 generations on35descendants
- K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −4 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −3 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −2 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −1 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| 0 (this device) | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | — |
| +1 | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | 16 |
| +2 | K102975 | Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole | Exactech, Inc. | 2010 | — |
| +3 | K122798 | Integrip Acetabular Shell, Integrip Revision Acetabular Shell | Exactech, Inc. | 2012 | — |
| +3 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| +3 | K112898 | Delta TT Cups, Delta TT Liners, Bone Screws | Lima Corporate S.P.A. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (3)
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 3…(k) # Clearance Product Date Code(s) AcuMatch® A-Series Porous Exactech K993082 11/19/1999 LPH & JDI Coated Acetabular Cornponent AcuMatch® A-Series and Exactech K040613 06/4/200… | 1999 |
| * | K040613 | Exactech Acumatch a-Series and MCS Acetabular Shells and LinersSummary page 3…) AcuMatch® A-Series Porous Exactech K993082 11/19/1999 LPH & JDI Coated Acetabular Cornponent AcuMatch® A-Series and Exactech K040613 06/4/2004 JDI, LPH & MCS Acetabular Shells & MEH Liners AcuMatch… | 2004 |
| * | K041906 | Exactech 12/14 Total Hip SystemSummary page 3…06/4/2004 JDI, LPH & MCS Acetabular Shells & MEH Liners AcuMatch® A-Series 36mm Exactech K041906 09/10/2004 LPH, LZO, Acetabular Liner, 12/14 MEH, LWJ Femoral Head an… | 2004 |
What descends from it? (60)
See all 602 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2022 | Class II | Z-1728-2022 | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| Jun 29, 2021 | Class II | Z-2121-2021 | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Class II | Z-2122-2021 | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Class II | Z-2117-2021 | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Class II | Z-2131-2021 | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Class II | Z-2118-2021 | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Class II | Z-2112-2021 | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Class II | Z-2113-2021 | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Class II | Z-2116-2021 | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Class II | Z-2124-2021 | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Class II | Z-2133-2021 | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Class II | Z-2114-2021 | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K070479 (Exactech, Inc., 2007) has gone furthest, with 59 descendants of its own.
- 8 other devices also cite its predicate K993082.
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?
AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051556: Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051556
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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