510(k) · Cleared
ClearedCI../..X liner for NOVAE Dual Mobility Acetabular Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Serf · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jan 15, 2015 as substantially equivalent to K111572 (Serf, 2011) and 1 other predicate after a 118-day review. Its family tree reaches back 7 generations to 1993. 3 later devices descend from it.
- Decided
- Jan 15, 2015
- Review
- 118 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K930712 (1993). 28 ancestors in all, the oldest K913231 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 6 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 5 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 4 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 3 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- 2 generations backK073150 Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008
- 1 generation backK100555 Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc. · 2010 · Recalled
- This deviceK142675 CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf · 2015
- Descendant · cites it directly · 2 of its ownK211742 SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK220495 SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK243456 ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd. · 2022 · cites it directly2descendants
- K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd. · 2023 · cites it directly1descendant
- K243456ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −6 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −5 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −4 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| −2 | K073150 | Apex-LNK Poly Acetabular Cup Liners | Omni Life Science, Inc. | 2008 | — |
| −1 | K100555 | Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK | Omni Life Science, Inc. | 2010 | 1 |
| 0 (this device) | K142675 | CI../..X liner for NOVAE Dual Mobility Acetabular Cup | Serf | 2015 | — |
| +1 | K211742 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2022 | — |
| +1 | K220495 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2023 | — |
| +2 | K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH…Summary page 4…hylene which meet the strength requirements of the ASTM F648 and the testing listed in the ASTM F2565. The liner is mobile (free) in the NOVAE® metallic shell (clearance K111572) and retained on the prosthetic femoral head. Liners can be used with ‡22.2 or 28 mm prosthetic femoral heads. Substantial equiv… | 2011 |
| * | K100555 | Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKSummary page 4…zes, mechanical safety and performances. The CI../..X liner for NOVAE® Dual Mobility Acetabular Cup is substantially equivalent to ApeX- LNK PolyTM Acetabular Cup Liner (K100555, OMNIlife science) in terms of intended use, material and manufacturing and sterilization processes.… | 2010 |
What descends from it? (3)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K211742 (Signature Orthopaedics Pty, Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 9 other devices also cite its predicate K111572.
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. 2015, 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?
NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:
x Osteoarthritis
x Femoral neck fracture
x Dislocation risk
x Osteonecrosis of the femoral head
x Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142675: CI../..X liner for NOVAE Dual Mobility Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142675
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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