510(k) · Cleared
ClearedNEXUS® Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on May 15, 2025 as substantially equivalent to K200007 (Microport Orthopedics, Inc., 2020) and 4 other predicates after a 90-day review. Its family tree reaches back 16 generations to 1994. 2 of the 189 devices in its family, counting itself, have a Class I recall.
- Decided
- May 15, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K941847 (1994). 189 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet. 2 of the 189 devices in this family, counting this one, have a Class I recall.
- 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 deviceK250444 NEXUS® Hip StemMicroport Orthopedics, Inc. · 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 deviceK250444 NEXUS® Hip StemMicroport Orthopedics, Inc. · 2025
Class I recalls in this family
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) | K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 19 | 0 |
| 1995 | 12 | 0 |
| 1996 | 12 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 18 | 0 |
| 2001 | 10 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 1 |
| 2010 | 4 | 1 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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.
2 devices in this family have a Class I recall. 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? (5)
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 |
|---|---|---|---|
| * | K200007 | PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarSummary page 5…3353 Product Code(s) LZO, MEH I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K200007 PROFEMUR Gladiator Thin HA Classic Hip Stem with Collar LZO K150302 PROFEMUR Preserve Classic Stem LZO K150862 DePuy Actis DuoFix… | 2020 |
| * | K150302 | PROFEMUR Preserve Classic StemSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K200007 PROFEMUR Gladiator Thin HA Classic Hip Stem with Collar LZO K150302 PROFEMUR Preserve Classic Stem LZO K150862 DePuy Actis DuoFix Hip Prosthesis MEH K160907 DePuy Actis DuoFix Hip Prosthesis MEH K1… | 2015 |
| * | K150862 | DePuy Actis Duofox Hip ProsthesisSummary page 5…rade Name (Primary Predicate is listed first) Product Code K200007 PROFEMUR Gladiator Thin HA Classic Hip Stem with Collar LZO K150302 PROFEMUR Preserve Classic Stem LZO K150862 DePuy Actis DuoFix Hip Prosthesis MEH K160907 DePuy Actis DuoFix Hip Prosthesis MEH K191632 PROFEMUR TL2 Stems LZO Device Descrip… | 2015 |
| * | K160907 | DePuy Actis DuoFix Hip ProsthesisSummary page 5…Product Code K200007 PROFEMUR Gladiator Thin HA Classic Hip Stem with Collar LZO K150302 PROFEMUR Preserve Classic Stem LZO K150862 DePuy Actis DuoFix Hip Prosthesis MEH K160907 DePuy Actis DuoFix Hip Prosthesis MEH K191632 PROFEMUR TL2 Stems LZO Device Description Summary 21 CFR 807.92(a)(4) The MicroPor… | 2016 |
| * | K191632 | PROFEMUR TL2 StemsSummary page 5…A Classic Hip Stem with Collar LZO K150302 PROFEMUR Preserve Classic Stem LZO K150862 DePuy Actis DuoFix Hip Prosthesis MEH K160907 DePuy Actis DuoFix Hip Prosthesis MEH K191632 PROFEMUR TL2 Stems LZO Device Description Summary 21 CFR 807.92(a)(4) The MicroPort NEXUS® Hip Stem is manufactured from titaniu… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · 3 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 47 of the 188 ancestors have a recall of any class; 2 have a Class I recall.
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. 2025, 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?
NEXUS® Hip stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or
improved hip function in skeletally mature patients.
1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis,
protrusio acetabuli, and painful hip dysplasia;
2) inflammatory degenerative joint disease such as rheumatoid arthritis;
3) correction of functional deformity; and,
4) revision procedures where other treatments or devices have failed
Titanium plasma spray and HA coatings applied to implant surfaces are intended for uncemented
arthroplasty.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250444 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250444: NEXUS® Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250444
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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