510(k) · Cleared
Recalled · Class II · 2022Exactech Novation Crown Cup and Liners
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 Mar 15, 2007 as substantially equivalent to K993082 (Exactech, Inc., 1999) and 2 other predicates after a 23-day review. Its family tree reaches back 6 generations to 1994. 59 later devices descend from it. It has been recalled 16 times.
- Decided
- Mar 15, 2007
- Review
- 23 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 16
- Predicates
- 3
Its longest line of descent runs back 6 generations to K931641 (1994). 20 ancestors in all, the oldest K862234 (1986). 59 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 4 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 3 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 2 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 1 generation backK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- This deviceK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007
- Descendant · cites it directly · 53 of its ownK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
- Descendant · 2 generations on · 36 of its ownK122798 Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc. · 2012
- Descendant · 2 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- Descendant · 2 generations on · 12 of its ownK112898 Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012
- Descendant · 3 generations on · 10 of its ownK141395 Delta TT Acetabular SystemLima Corporate S.P.A. · 2014 · Recalled
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010 · cites it directly53descendants
- K122798Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc. · 2012 · 2 generations on36descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 2 generations on35descendants
- K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012 · 2 generations on12descendants
- K141395Delta TT Acetabular SystemLima Corporate S.P.A. · 2014 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −5 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −4 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −3 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −2 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −1 | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | 12 |
| 0 (this device) | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | — |
| +1 | K102975 | Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole | Exactech, Inc. | 2010 | — |
| +2 | K122798 | Integrip Acetabular Shell, Integrip Revision Acetabular Shell | Exactech, Inc. | 2012 | — |
| +2 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| +2 | K112898 | Delta TT Cups, Delta TT Liners, Bone Screws | Lima Corporate S.P.A. | 2012 | — |
| +3 | K141395 | Delta TT Acetabular System | Lima Corporate S.P.A. | 2014 | 1 |
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 |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentSummary page 2…r Proprietary or Model Name Manufacturer Number #K993082 AcuMatch A-Series Porous Coated Cups and Liners… | 1999 |
| * | K000242 | Acumatch a-Series Corundum Acetabular Component and Acumatch a-Series Corundum…Summary page 2…AcuMatch A-Series Porous Coated Cups and Liners Exactech, Inc. #K000242 AcuMatch A-Series Corundum Cups… | 2000 |
| * | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneSummary page 2…AcuMatch A-Series Corundum Cups Exactech, Inc. #K051556 AcuMatch A-Series GXL Liners… | 2005 |
What descends from it? (59)
See all 596 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102975 | Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole | 2010 | 53 |
| K100269 | Novation Crown Cup GXL Liners | 2010 | 5 |
| K121392 | Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 Degree | 2013 | 4 |
| K173583 | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | 2018 | 3 |
| K182502 | Alteon Acetabular Cup System | 2019 | 2 |
| K141960 | Exactech® Novation® Crown Cup® | 2015 | 0 |
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-1729-2022 | 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-2128-2021 | 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-2132-2021 | 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-2126-2021 | 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. |
| 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-2127-2021 | 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. |
| Nov 5, 2012 | Class II | Z-0787-2013 | Labeling mix-ups | Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed. |
| Nov 5, 2012 | Class II | Z-0788-2013 | Labeling mix-ups | Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed. |
The 5 latest of 16 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 13 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 20 ancestors have a recall of any class.
- Of its descendants, K102975 (Exactech, Inc., 2010) has gone furthest, with 53 descendants of its own.
- 8 other devices also cite its predicate K993082.
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. 2007, 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 (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/K070479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070479: Exactech Novation Crown Cup and Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070479
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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