510(k) · Cleared
Recalled · Class II · 2024Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Cleared on Mar 12, 2018 as substantially equivalent to K051556 (Exactech, Inc., 2005) and 4 other predicates after a 112-day review. Its family tree reaches back 12 generations to 1981. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 12, 2018
- Review
- 112 days
- Class
- Class II
- Product code
- OQI
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 12 generations to K810258 (1981). 126 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations between
- 3 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 2 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 1 generation backK111481 Corin Trinity Acetabular System Ecima LinersCorin USA · 2012 · Recalled
- This deviceK173583 Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK182502 Alteon Acetabular Cup SystemExactech, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK210614 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK223223 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2023
Show all 12 generations
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 10 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 9 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 8 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 7 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 6 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 5 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 4 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 3 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 2 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 1 generation backK111481 Corin Trinity Acetabular System Ecima LinersCorin USA · 2012 · Recalled
- This deviceK173583 Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −11 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −10 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −9 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −8 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −7 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −6 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −5 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −4 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −3 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −2 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −1 | K111481 | Corin Trinity Acetabular System Ecima Liners | Corin USA | 2012 | 1 |
| 0 (this device) | K173583 | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | Exactech, Inc. | 2018 | — |
| +1 | K182502 | Alteon Acetabular Cup System | Exactech, Inc. | 2019 | 2 |
| +2 | K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2022 | — |
| +3 | K223223 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 14 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 15 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 OQI? 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 OQI device
- #1 K252451 EPORE® XO cup systemscore 15.1 · 14 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneSummary page 4…, LZO, MEH Legally Marketed Device to Which Substantial Equivalence Is Claimed: x Exatech® AcuMatch® A-Series Connexion GXL Enhanced UHMWPE Acetabular Liner (K051556) x Exactech Novation® Crown Cup® and Liners (K070479) x Exactech Novation®Crown Cup® and Liners (K100269) x Exactech Nov… | 2005 |
| * | K070479 | Exactech Novation Crown Cup and LinersSummary page 4…l Equivalence Is Claimed: x Exatech® AcuMatch® A-Series Connexion GXL Enhanced UHMWPE Acetabular Liner (K051556) x Exactech Novation® Crown Cup® and Liners (K070479) x Exactech Novation®Crown Cup® and Liners (K100269) x Exactech Novation® Crown Cup® GXL UHMWPE Liner (K121392) x Corin… | 2007 |
| * | K100269 | Novation Crown Cup GXL LinersSummary page 4…ies Connexion GXL Enhanced UHMWPE Acetabular Liner (K051556) x Exactech Novation® Crown Cup® and Liners (K070479) x Exactech Novation®Crown Cup® and Liners (K100269) x Exactech Novation® Crown Cup® GXL UHMWPE Liner (K121392) x Corin Trinity Acetabular System ECIMA Liners (K111481) Refer… | 2010 |
| * | K121392 | Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeSummary page 4…1556) x Exactech Novation® Crown Cup® and Liners (K070479) x Exactech Novation®Crown Cup® and Liners (K100269) x Exactech Novation® Crown Cup® GXL UHMWPE Liner (K121392) x Corin Trinity Acetabular System ECIMA Liners (K111481) Reference Devices x Biomet E1 Polyethylene Liners (K050327) Dev… | 2013 |
| * | K111481 | Corin Trinity Acetabular System Ecima LinersSummary page 4…) x Exactech Novation®Crown Cup® and Liners (K100269) x Exactech Novation® Crown Cup® GXL UHMWPE Liner (K121392) x Corin Trinity Acetabular System ECIMA Liners (K111481) Reference Devices x Biomet E1 Polyethylene Liners (K050327) Device Description Exactech Novation and AcuMatch E-HXL Acetabu… | 2012 |
| † | K050327 | E-Poly (Vitamin E) Acetabular Liners | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182502 | Alteon Acetabular Cup System | 2019 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 31, 2024 | Class II | Z-1166-2025 | Nonconforming Material/Component | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| Dec 31, 2024 | Class II | Z-1165-2025 | Nonconforming Material/Component | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| Nov 21, 2023 | Class II | Z-0577-2024 | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 36 of the 125 ancestors have a recall of any class.
- Of its descendants, K182502 (Exactech, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K051556.
How does its category compare?
All OQI devicesOQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OQI
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OQI
Too few OQI 510(k)s in any year since 2007 to give a median.
Recalls per year · OQI
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQI
45in 2025
MAUDE reports naming product code OQI, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 17 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 1 | 4 |
| 2023 | 0 | — | 1 | 23 |
| 2024 | 0 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 1 | — | 0 | — |
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…
Read the full statement (120 words)
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.
Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
Femoral heads and endoprostheses are intended for use in cemented and press-fit 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/K173583 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173583: Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K173583
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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