510(k) · Cleared
Recalled · Class II · 2020Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility Acetabular Cup Model
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 Aug 29, 2011 as substantially equivalent to K070278 (Plus Orthopedics AG, 2007) and 2 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1999. 27 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 29, 2011
- Review
- 84 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 2 generations to K991990 (1999). 3 ancestors in all. 27 later devices descend from it, 10 citing it directly.
- Root · 2 generations backK991990 Tri-Polar SystemBiomet, Inc. · 1999
- 1 generation backK070278 Polarcup Dual Mobility SystemPlus Orthopedics AG · 2007
- This deviceK111572 Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH…Serf · 2011
- Descendant · cites it directly · 10 of its ownK181744 BI-MENTUM dual mobility systemSerf · 2018
- Descendant · 2 generations on · 6 of its ownK203532 BI-MENTUM™ ALTRX® Dual Mobility LinerDepuy Ireland UC · 2021
- Descendant · 3 generations on · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- Descendant · cites it directly · 4 of its ownK171273 LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG · 2018 · Recalled
- Descendant · cites it directly · 3 of its ownK191831 MobiliT CupCorin U.S.A. Limited · 2020
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K181744BI-MENTUM dual mobility systemSerf · 2018 · cites it directly10descendants
- K203532BI-MENTUM™ ALTRX® Dual Mobility LinerDepuy Ireland UC · 2021 · 2 generations on6descendants
- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · 3 generations on5descendants
- K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG · 2018 · cites it directly4descendants
- K191831MobiliT CupCorin U.S.A. Limited · 2020 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991990 | Tri-Polar System | Biomet, Inc. | 1999 | — |
| −1 | K070278 | Polarcup Dual Mobility System | Plus Orthopedics AG | 2007 | — |
| 0 (this device) | K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back)… | Serf | 2011 | — |
| +1 | K181744 | BI-MENTUM dual mobility system | Serf | 2018 | — |
| +2 | K203532 | BI-MENTUM™ ALTRX® Dual Mobility Liner | Depuy Ireland UC | 2021 | — |
| +3 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| +1 | K171273 | LINK® BiMobile (TM) Dual Mobility System | Waldemar Link GmbH & Co. KG | 2018 | 2 |
| +1 | K191831 | MobiliT Cup | Corin U.S.A. Limited | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K070278 | Polarcup Dual Mobility SystemSummary page 2…832-1:2007. Substantial equivalence claimed to predicate devices NOVAE® Dual Mobility Acetabular Cup is substantially equivalent to the POLARCUP® dual mobility system (K070278, PLUS Orthopedics) in terms of intended use, design, range of sizes, materials used, mechanical safety and performances, the Rest… | 2007 |
| * | K072020 | Restoration Adm SystemSummary page 2…ty system (K070278, PLUS Orthopedics) in terms of intended use, design, range of sizes, materials used, mechanical safety and performances, the Restoration TmADM system (K072020, Stryker) in terms of intended use, design and metal-back coating and the Tni-Polar system and RingLocO + modular acetabular shel… | 2007 |
| * | K991990 | Tri-Polar SystemSummary page 2…the Restoration TmADM system (K072020, Stryker) in terms of intended use, design and metal-back coating and the Tni-Polar system and RingLocO + modular acetabular shell (K991990, BIOMET) in terms of intended use, design and range of sizes. NOVAE D… | 1999 |
What descends from it? (27)
See all 2710 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181744 | BI-MENTUM dual mobility system | 2018 | 10 |
| K171273 | LINK® BiMobile (TM) Dual Mobility System | 2018 | 4 |
| K191831 | MobiliT Cup | 2020 | 3 |
| K142675 | CI../..X liner for NOVAE Dual Mobility Acetabular Cup | 2015 | 3 |
| K211742 | SignaSure Dual Mobility System | 2022 | 2 |
| K223745 | Novae® Dual Mobility System, Hype® Hip System | 2023 | 1 |
| K220495 | SignaSure Dual Mobility System | 2023 | 1 |
| K152919 | OMNI Skirted Heads | 2016 | 1 |
| K250989 | Stryker and Serf hip devices | 2025 | 0 |
| K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2020 | Class II | Z-0920-2021 | Under Investigation by firm | Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery |
| Dec 21, 2020 | Class II | Z-0921-2021 | Under Investigation by firm | Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery |
| Dec 21, 2020 | Class II | Z-0922-2021 | Under Investigation by firm | Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery |
| Jul 23, 2019 | Class II | Z-2479-2019 | Nonconforming Material/Component | Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery. |
| Jul 23, 2019 | Class II | Z-2480-2019 | Nonconforming Material/Component | Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K181744 (Serf, 2018) has gone furthest, with 10 descendants of its own.
- 7 other devices also cite its predicate K070278.
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. 2011, 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:
* Osteoarthritis
* Femoral neck fracture
* Dislocation risk
* Osteonecrosis of the femoral head
* 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/K111572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111572: Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility Acetabular Cup Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111572
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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