510(k) Report

510(k) · Cleared

Cleared

Initia Total Hip System & BIOCERAM AZUL (R) HEAD

K160895510(k) TraditionalCleared Nov 1, 2016215-day reviewClass II21 CFR 888.3353

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kyocera Medical Corporation · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Nov 1, 2016 as substantially equivalent to K043537 (Biomet, Inc., 2005) and 18 other predicates after a 215-day review. Its family tree reaches back 10 generations to 1981. 2 later devices descend from it.

Decided
Nov 1, 2016
Review
215 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
19

Its longest line of descent runs back 10 generations to K810258 (1981). 127 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2010: 2 other ancestors2008: 2 other ancestors2006: 4 other ancestors2005: 6 other ancestors2001: 4 other ancestors2000: 12 other ancestors1999: 5 other ancestors1998: 6 other ancestors1995: 14 other ancestors1994: 17 other ancestors1988: 1 other ancestor2011: 1 other ancestor2009: 1 other ancestor2007: 2 other ancestors2004: 2 other ancestors2003: 4 other ancestors2002: 7 other ancestors1997: 7 other ancestors1996: 8 other ancestors1990: 1 other ancestor1985: 2 other ancestors1983: 1 other ancestor1993: 2 other ancestors1992: 3 other ancestors1986: 1 other ancestor1991: 1 other ancestor2024: 1 descendant cleared2025: 1 descendant clearedK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010K112115 · Mectacer Biolox (R) Delta Femoral Heads · Medacta International · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 17 other ancestors2 generations back: 26 other ancestors3 generations back: 32 other ancestors4 generations back: 36 other ancestors5 generations back: 5 other ancestors6 generations back: 1 other ancestor 1 generation forward: 2 descendants K112115 · Mectacer Biolox (R) Delta Femoral Heads · Medacta International · 2011K100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010K082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K051411 · Arcomxl Polyethylene Liners and Biolox Delta Heads · Biomet, Inc. · 2005 · recalledK042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalledK032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−10−50
  1. Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 6 generations between
  3. 3 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  4. 2 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  5. 1 generation backK112115 Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011
  6. This deviceK160895 Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016
  7. Descendant · cites it directly · 0 of its ownK242045 Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc. · 2025
  8. Descendant · cites it directly · 0 of its ownK243444 Bioceram Azul® HeadKyocera Corporation · 2024
Show all 10 generations
  1. Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 7 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 6 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 5 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 4 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  8. 3 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  9. 2 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  10. 1 generation backK112115 Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011
  11. This deviceK160895 Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016

Most influential descendants

Showing 2 of 2 · See all
  • K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc. · 2025 · cites it directly0descendants
  • K243444Bioceram Azul® HeadKyocera Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−9K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−8K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−7K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−6K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−5K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−4K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20073
−3K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…Encore Medical L.P.20081
−2K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010—
−1K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International2011—
0 (this device)K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation2016—
+1K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.2025—
+1K243444Bioceram Azul® HeadKyocera Corporation2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198520
198610
198810
199010
199110
199230
199320
1994170
1995140
199680
199770
199860
199950
2000120
200140
200270
200340
200420
200560
200640
200720
200820
200910
201020
201110
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202510
FIG. 1 — Lineage of K160895, 1981–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (19)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K043537Taperloc 12/14 Taper Femoral Components
Summary page 6
…K160895 p.2/4 PREDICATE DEVICES: • Biomet, Taperloc® 12/14 Taper Femoral Components (K043537) • Howmedica Osteonics Accolade II Hip Stem (K120578) • DePuy, Focus Total Hip System, Articul/eze Femoral Heads and Mo…
Biomet, Inc.2005—
*K120578Accolade II Hip Stem
Summary page 6
…K160895 p.2/4 PREDICATE DEVICES: • Biomet, Taperloc® 12/14 Taper Femoral Components (K043537) • Howmedica Osteonics Accolade II Hip Stem (K120578) • DePuy, Focus Total Hip System, Articul/eze Femoral Heads and Modular M Heads (K883460, K980513, K060031) • Bi…
Howmedica Osteonics20121
*K883460Focus Total Hip System
Summary page 6
…omponents (K043537) • Howmedica Osteonics Accolade II Hip Stem (K120578) • DePuy, Focus Total Hip System, Articul/eze Femoral Heads and Modular M Heads (K883460, K980513, K060031) • Biomet, Porous Plasma Spray (PPS) Ringloc® + Acetabular System (K093235) • DePuy Orthopaedics Pinn…
Depuy, Inc.1988—
*K980513Articul/Eze Femoral Heads
Summary page 6
…(K043537) • Howmedica Osteonics Accolade II Hip Stem (K120578) • DePuy, Focus Total Hip System, Articul/eze Femoral Heads and Modular M Heads (K883460, K980513, K060031) • Biomet, Porous Plasma Spray (PPS) Ringloc® + Acetabular System (K093235) • DePuy Orthopaedics Pinnacle Acet…
DePuy Orthopaedics, Inc.1998—
*K060031Depuy Modular M Heads
Summary page 6
…) • Howmedica Osteonics Accolade II Hip Stem (K120578) • DePuy, Focus Total Hip System, Articul/eze Femoral Heads and Modular M Heads (K883460, K980513, K060031) • Biomet, Porous Plasma Spray (PPS) Ringloc® + Acetabular System (K093235) • DePuy Orthopaedics Pinnacle Acetabular Sy…
DePuy Orthopaedics, Inc.2006—
*K093235Ringloc + Hybrid Acetabular System
Summary page 6
…Total Hip System, Articul/eze Femoral Heads and Modular M Heads (K883460, K980513, K060031) • Biomet, Porous Plasma Spray (PPS) Ringloc® + Acetabular System (K093235) • DePuy Orthopaedics Pinnacle Acetabular System (K000306) • Biomet ArcomXL Polyethylene Liners (K042051) • DePuy,…
Biomet, Inc.201030
*K000306Pinnacle Acetabular System
Summary page 6
…(K883460, K980513, K060031) • Biomet, Porous Plasma Spray (PPS) Ringloc® + Acetabular System (K093235) • DePuy Orthopaedics Pinnacle Acetabular System (K000306) • Biomet ArcomXL Polyethylene Liners (K042051) • DePuy, DePuy Pinnacle® AltrXTM Acetabular Liners (K072963, K102423)…
DePuy Orthopaedics, Inc.20001
*K042051Arcomxl Polyethylene Liners
Summary page 6
…orous Plasma Spray (PPS) Ringloc® + Acetabular System (K093235) • DePuy Orthopaedics Pinnacle Acetabular System (K000306) • Biomet ArcomXL Polyethylene Liners (K042051) • DePuy, DePuy Pinnacle® AltrXTM Acetabular Liners (K072963, K102423) • Medacta International Mectacer Biolox Delta He…
Biomet, Inc.20051
*K072963Depuy Pinnacle Altrx Acetabular Liners
Summary page 6
…• DePuy Orthopaedics Pinnacle Acetabular System (K000306) • Biomet ArcomXL Polyethylene Liners (K042051) • DePuy, DePuy Pinnacle® AltrXTM Acetabular Liners (K072963, K102423) • Medacta International Mectacer Biolox Delta Heads (K112115) • Smith & Nephew, Reflection® Cross-linked UHMW…
DePuy Orthopaedics, Inc.2008—
*K102423Depuy Pinnacle Altrx Acetabular Liners
Summary page 6
…y Orthopaedics Pinnacle Acetabular System (K000306) • Biomet ArcomXL Polyethylene Liners (K042051) • DePuy, DePuy Pinnacle® AltrXTM Acetabular Liners (K072963, K102423) • Medacta International Mectacer Biolox Delta Heads (K112115) • Smith & Nephew, Reflection® Cross-linked UHMWPE Acetab…
DePuy Orthopaedics, Inc.20102
*K112115Mectacer Biolox (R) Delta Femoral Heads
Summary page 6
…rcomXL Polyethylene Liners (K042051) • DePuy, DePuy Pinnacle® AltrXTM Acetabular Liners (K072963, K102423) • Medacta International Mectacer Biolox Delta Heads (K112115) • Smith & Nephew, Reflection® Cross-linked UHMWPE Acetabular Components (K932755, K991026, K002747, K013658) •…
Medacta International2011—
*K932755Reflection Acetabular Component
Summary page 6
…K072963, K102423) • Medacta International Mectacer Biolox Delta Heads (K112115) • Smith & Nephew, Reflection® Cross-linked UHMWPE Acetabular Components (K932755, K991026, K002747, K013658) • Encore Orthopedics, 6.5 mm Cancellous Bone Screw (K931665) • Howmedica Osteonics, Trident…
Smith & Nephew Richards, Inc.1994—
*K991026Reflection Crosslinked Uhmwpe Acetabular Components
Summary page 6
…K102423) • Medacta International Mectacer Biolox Delta Heads (K112115) • Smith & Nephew, Reflection® Cross-linked UHMWPE Acetabular Components (K932755, K991026, K002747, K013658) • Encore Orthopedics, 6.5 mm Cancellous Bone Screw (K931665) • Howmedica Osteonics, Trident® Hip Sys…
Smith & Nephew, Inc.19991
*K002747Reflection Cross-Linked Uhmwpe Acetabular Components
Summary page 6
…• Medacta International Mectacer Biolox Delta Heads (K112115) • Smith & Nephew, Reflection® Cross-linked UHMWPE Acetabular Components (K932755, K991026, K002747, K013658) • Encore Orthopedics, 6.5 mm Cancellous Bone Screw (K931665) • Howmedica Osteonics, Trident® Hip System (K033…
Smith & Nephew, Inc.2000—
*K013658Modification to Reflection Cross-Linked Uhmwpe Acetabular Components
Summary page 6
…dacta International Mectacer Biolox Delta Heads (K112115) • Smith & Nephew, Reflection® Cross-linked UHMWPE Acetabular Components (K932755, K991026, K002747, K013658) • Encore Orthopedics, 6.5 mm Cancellous Bone Screw (K931665) • Howmedica Osteonics, Trident® Hip System (K033716)…
Smith & Nephew, Inc.2001—
*K9316656.5 MM Cancellous Bone Screw
Summary page 6
…mith & Nephew, Reflection® Cross-linked UHMWPE Acetabular Components (K932755, K991026, K002747, K013658) • Encore Orthopedics, 6.5 mm Cancellous Bone Screw (K931665) • Howmedica Osteonics, Trident® Hip System (K033716) • Howmedica Osteonics, CrossfireTM System 12® Acetabular Inserts…
Encore Orthopedics, Inc.19942
*K033716Trident Acetabular System
Summary page 6
…Components (K932755, K991026, K002747, K013658) • Encore Orthopedics, 6.5 mm Cancellous Bone Screw (K931665) • Howmedica Osteonics, Trident® Hip System (K033716) • Howmedica Osteonics, CrossfireTM System 12® Acetabular Inserts (K993352) • Howmedica Corp., Howmedica ® Acetabular C…
Howmedica Osteonics Corp.20052
*K993352Crossfire System 12 Acetabular Inserts
Summary page 6
…, 6.5 mm Cancellous Bone Screw (K931665) • Howmedica Osteonics, Trident® Hip System (K033716) • Howmedica Osteonics, CrossfireTM System 12® Acetabular Inserts (K993352) • Howmedica Corp., Howmedica ® Acetabular Comp Pack/Manuf Meth (K934060) DEVICE DESCRIPTION: The Initia Total Hip System…
Howmedica Osteonics Corp.1999—
*K934060Howmedica (R) Acetabular Comp Pack/Manuf Meth Change
Summary page 6
…Hip System (K033716) • Howmedica Osteonics, CrossfireTM System 12® Acetabular Inserts (K993352) • Howmedica Corp., Howmedica ® Acetabular Comp Pack/Manuf Meth (K934060) DEVICE DESCRIPTION: The Initia Total Hip System is comprised of femoral stems, Co-Cr femoral heads, acetabular shells, an api…
Howmedica Corp.1995—

Also cleared against K043537: 19 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250
K243444Bioceram Azul® HeadKyocera Corporation20240

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 35 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
  • 36 of the 127 ancestors have a recall of any class.
  • Of its descendants, K242045 (Kyocera Medical Technologies, Inc., 2025) has gone furthest, with 0 descendants of its own.
  • 19 other devices also cite its predicate K043537.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

What is it indicated for?

The Initia Total Hip System is a single use total hip system for use in cementless hip arthroplasty procedures for the following indications: - Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis, - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure, - Clinical management problems where arthrodesis or…

Read the full statement (175 words)

The Initia Total Hip System is a single use total hip system for use in cementless hip arthroplasty procedures for the following indications:

- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,

- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,

- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results,

The Initia Total Hip System femoral stems are intended for cementless press-fit use. The Initia Total Hip System acetabular shells are intended for cementless use with biological fixation.

The BIOCERAM AZUL HEAD is a single use modular femoral head component for use in hip arthroplasty procedures for the following indications:

- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,

- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,

- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Indications for use as stated in the FDA summary.

Also cleared against K043537

19 other devices cite the same predicate.

  • K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc. · 2019
  • K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019
  • K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
  • K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015
  • K141327Minima S SystemLima Corporate S.P.A. · 2014
  • K140975Mastersl Femoral StemLima Corporate S.P.A. · 2014

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K160895 · printed Nov 4, 2026

Cite this page

510(k) Report. “K160895: Initia Total Hip System & BIOCERAM AZUL (R) HEAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160895

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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