510(k) · Cleared
Recalled · Class II · 2022Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 Degree
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jan 16, 2013 as substantially equivalent to K070479 (Exactech, Inc., 2007) and 2 other predicates after a 252-day review. Its family tree reaches back 7 generations to 1994. 4 later devices descend from it. It has been recalled 7 times.
- Decided
- Jan 16, 2013
- Review
- 252 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 7 generations to K931641 (1994). 28 ancestors in all, the oldest K862234 (1986). 4 later devices descend from it, 1 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 deviceK121392 Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10…Exactech, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK173583 Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK182502 Alteon Acetabular Cup SystemExactech, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 1 of its ownK210614 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK223223 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. · 2018 · cites it directly3descendants
- K182502Alteon Acetabular Cup SystemExactech, Inc. · 2019 · 2 generations on2descendants
- K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022 · 3 generations on1descendant
- K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2023 · 4 generations on0descendants
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) | K121392 | Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 Degree | Exactech, Inc. | 2013 | — |
| +1 | K173583 | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | Exactech, Inc. | 2018 | 3 |
| +2 | K182502 | Alteon Acetabular Cup System | Exactech, Inc. | 2019 | 2 |
| +3 | K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2022 | — |
| +4 | K223223 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 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 |
|---|---|---|---|
| * | K070479 | Exactech Novation Crown Cup and LinersSummary page 2…Effectiveness Information on devices to which substantial equivalence is claimed: 510(k) Number Trade of Proprietary Model Name Manufacturer K070479 Exactech Novation® Crown Cup® Liners Exactech, Inc. K041906 Exactech 12/14 CoCr Femoral Hea… | 2007 |
| * | K041906 | Exactech 12/14 Total Hip SystemSummary page 2…0(k) Number Trade of Proprietary Model Name Manufacturer K070479 Exactech Novation® Crown Cup® Liners Exactech, Inc. K041906 Exactech 12/14 CoCr Femoral Heads Exactech, Inc. K103012 Exactech Bioloxdelta® and Biolo… | 2004 |
| * | K103012 | Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM OD, Exactech Biolox…Summary page 2…479 Exactech Novation® Crown Cup® Liners Exactech, Inc. K041906 Exactech 12/14 CoCr Femoral Heads Exactech, Inc. K103012 Exactech Bioloxdelta® and Biolox Option Exactech, Inc. Femoral Heads and Adapters Ind… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173583 | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | 2018 | 3 |
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-1732-2022 | 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-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-2119-2021 | 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-2129-2021 | 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-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-2123-2021 | 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 19 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 28 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 LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 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 (123 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 as stated in the FDA summary.
https://510kreport.com/device/K121392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121392: Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 Degree.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121392
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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