510(k) · Cleared
ClearedNovae® Dual Mobility System, Hype® Hip System
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 Dec 22, 2023 as substantially equivalent to K181744 (Serf, 2018) and 10 other predicates after a 373-day review. Its family tree reaches back 16 generations to 1994. 1 later device descends from it.
- Decided
- Dec 22, 2023
- Review
- 373 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 16 generations to K941847 (1994). 200 ancestors in all, the oldest K802627 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 16 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations between
- 3 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 2 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 1 generation backK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
- This deviceK223745 Novae® Dual Mobility System, Hype® Hip SystemSerf · 2023
- Descendant · cites it directly · 0 of its ownK250989 Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025
Show all 16 generations
- Root · 16 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 15 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 14 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 13 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 12 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 11 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 10 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 9 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 8 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 7 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 6 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 5 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 4 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 3 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 2 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 1 generation backK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
- This deviceK223745 Novae® Dual Mobility System, Hype® Hip SystemSerf · 2023
Most influential descendants
Showing 1 of 1 · See all- K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −15 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −14 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −13 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −12 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −11 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −10 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −9 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −8 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −7 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −6 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −5 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −4 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −3 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −2 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −1 | K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy (Ireland) | 2016 | — |
| 0 (this device) | K223745 | Novae® Dual Mobility System, Hype® Hip System | Serf | 2023 | — |
| +1 | K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 20 | 0 |
| 1995 | 16 | 0 |
| 1996 | 13 | 0 |
| 1997 | 8 | 0 |
| 1998 | 10 | 0 |
| 1999 | 6 | 0 |
| 2000 | 18 | 0 |
| 2001 | 10 | 0 |
| 2002 | 10 | 0 |
| 2003 | 7 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (11)
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 |
|---|---|---|---|
| * | K181744 | BI-MENTUM dual mobility systemSummary page 5…LZO, MEH Classification Panel: Orthopedic Regulation Number: Primary regulation: 21 C.F.R. § 888.3353 C1. PRIMARY PREDICATE DEVICE K181744 Serf BI-MENTUMTM dual mobility system C2. PREDICATE DEVICES K111572 Serf NOV… | 2018 |
| * | K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH…Summary page 5…Primary regulation: 21 C.F.R. § 888.3353 C1. PRIMARY PREDICATE DEVICE K181744 Serf BI-MENTUMTM dual mobility system C2. PREDICATE DEVICES K111572 Serf NOVAE® dual mobility acetabular cup K190344, K123991, K042992 DePuy Corail Hip Prosthesis… | 2011 |
| * | K190344 | DePuy Corail AMT Hip ProsthesisSummary page 5…K181744 Serf BI-MENTUMTM dual mobility system C2. PREDICATE DEVICES K111572 Serf NOVAE® dual mobility acetabular cup K190344, K123991, K042992 DePuy Corail Hip Prosthesis K082239, K042959 DePuy C-Stem AMT K160907, K150862… | 2019 |
| * | K123991 | Depuy Corail Amt Hip ProsthesisSummary page 5…Serf BI-MENTUMTM dual mobility system C2. PREDICATE DEVICES K111572 Serf NOVAE® dual mobility acetabular cup K190344, K123991, K042992 DePuy Corail Hip Prosthesis K082239, K042959 DePuy C-Stem AMT K160907, K150862… | 2013 |
| * | K042992 | Corail Amt Hip ProsthesisSummary page 5…Serf BI-MENTUMTM dual mobility system C2. PREDICATE DEVICES K111572 Serf NOVAE® dual mobility acetabular cup K190344, K123991, K042992 DePuy Corail Hip Prosthesis K082239, K042959 DePuy C-Stem AMT K160907, K150862 DePuy Ac… | 2005 |
| * | K082239 | Depuy C-Stem AmtSummary page 5…ty system C2. PREDICATE DEVICES K111572 Serf NOVAE® dual mobility acetabular cup K190344, K123991, K042992 DePuy Corail Hip Prosthesis K082239, K042959 DePuy C-Stem AMT K160907, K150862 DePuy Actis Hip Prosthesis K980513, K011533… | 2008 |
| * | K042959 | Depuy C-Stem Amt Hip ProsthesisSummary page 5…C2. PREDICATE DEVICES K111572 Serf NOVAE® dual mobility acetabular cup K190344, K123991, K042992 DePuy Corail Hip Prosthesis K082239, K042959 DePuy C-Stem AMT K160907, K150862 DePuy Actis Hip Prosthesis K980513, K011533… | 2004 |
| * | K160907 | DePuy Actis DuoFix Hip ProsthesisSummary page 5…Serf NOVAE® dual mobility acetabular cup K190344, K123991, K042992 DePuy Corail Hip Prosthesis K082239, K042959 DePuy C-Stem AMT K160907, K150862 DePuy Actis Hip Prosthesis K980513, K011533 DePuy CoCrMo and Ceramic femoral heads ==… | 2016 |
| * | K150862 | DePuy Actis Duofox Hip ProsthesisSummary page 5…Serf NOVAE® dual mobility acetabular cup K190344, K123991, K042992 DePuy Corail Hip Prosthesis K082239, K042959 DePuy C-Stem AMT K160907, K150862 DePuy Actis Hip Prosthesis K980513, K011533 DePuy CoCrMo and Ceramic femoral heads === Page 6… | 2015 |
| * | K980513 | Articul/Eze Femoral HeadsSummary page 5…344, K123991, K042992 DePuy Corail Hip Prosthesis K082239, K042959 DePuy C-Stem AMT K160907, K150862 DePuy Actis Hip Prosthesis K980513, K011533 DePuy CoCrMo and Ceramic femoral heads… | 1998 |
| * | K011533 | Depuy Femoral HeadsSummary page 5…991, K042992 DePuy Corail Hip Prosthesis K082239, K042959 DePuy C-Stem AMT K160907, K150862 DePuy Actis Hip Prosthesis K980513, K011533 DePuy CoCrMo and Ceramic femoral heads… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250989 | Stryker and Serf hip devices | 2025 | 0 |
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 29 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 50 of the 199 ancestors have a recall of any class.
- Of its descendants, K250989 (Howmedica Osteonics Corp (Dba Stryker Orthopaedics), 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K181744.
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. 2023, 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?
The Novae® Dual Mobility and Hype® Hip Systems are 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 acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use.
Hype® SCS, SCC, SCL, SCV, SCC mini, and SCLA mini hip stems are intended for press-fit use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223745 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223745: Novae® Dual Mobility System, Hype® Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223745
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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