510(k) · Cleared
Recalled · Class II · 2022Novation Crown Cup GXL Liners
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 May 27, 2010 as substantially equivalent to K070479 (Exactech, Inc., 2007) after a 118-day review. Its family tree reaches back 7 generations to 1994. 5 later devices descend from it. It has been recalled 7 times.
- Decided
- May 27, 2010
- Review
- 118 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 7 generations to K931641 (1994). 21 ancestors in all, the oldest K862234 (1986). 5 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 6 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 5 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 4 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 3 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 2 generations backK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- 1 generation backK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
- This deviceK100269 Novation Crown Cup GXL LinersExactech, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK173583 Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. · 2018 · Recalled
- 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
- Descendant · cites it directly · 0 of its ownK141960 Exactech® Novation® Crown Cup®Exactech, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. · 2018 · cites it directly3descendants
- K182502Alteon Acetabular Cup SystemExactech, Inc. · 2019 · cites it directly2descendants
- K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022 · 2 generations on1descendant
- K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2023 · 3 generations on0descendants
- K141960Exactech® Novation® Crown Cup®Exactech, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −6 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −5 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −4 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −3 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −2 | 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 |
| 0 (this device) | K100269 | Novation Crown Cup GXL Liners | Exactech, Inc. | 2010 | — |
| +1 | K173583 | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | Exactech, Inc. | 2018 | 3 |
| +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 | — |
| +1 | K141960 | Exactech® Novation® Crown Cup® | Exactech, Inc. | 2015 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K070479 | Exactech Novation Crown Cup and LinersSummary page 1…Mlarketed Devices to Which Substantial Equivalence Is Claimed: 5 10(k) Number Trmde of Proprietary Model Name Manufacturer K070479 Novation® Crown Cup® and Liners Exactech, Inc IV. Device Description: Total Hip… | 2007 |
What descends from it? (5)
3 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-1731-2022 | 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-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-2130-2021 | 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-2115-2021 | 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-2125-2021 | 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-2120-2021 | 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 7 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 16 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 21 ancestors have a recall of any class.
- Of its descendants, K173583 (Exactech, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K070479.
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. 2010, this device’s year, is highlighted.
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 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 (142 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. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
* Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100269: Novation Crown Cup GXL Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100269
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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