510(k) · Cleared
ClearedCONDUIT Cages; FIBERGRAFT BG Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Oct 15, 2022 as substantially equivalent to K201605 (Eit Emerging Implant Technologies GmbH, 2020) and 2 other predicates after a 78-day review. Its family tree reaches back 25 generations to 1984. 1 of the 402 devices in its family, counting itself, has a Class I recall. 29 later devices descend from it.
- Decided
- Oct 15, 2022
- Review
- 78 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 25 generations to K841189 (1984). 372 ancestors in all. 29 later devices descend from it, 14 citing it directly. 1 of the 402 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 2 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 1 generation backK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
- This deviceK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
- Descendant · cites it directly · 11 of its ownK223731 NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023
- Descendant · 2 generations on · 9 of its ownK231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small…Nu Vasive, Incorporated · 2023
- Descendant · cites it directly · 4 of its ownK231076 VariLift®-C Interbody Fusion SystemWenzel Spine, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody…Alphatec Spine · 2025
- Descendant · 2 generations on · 2 of its ownK240830 Reef TO/TA System; Regatta Lateral System; Explorer TO System…Orthofix Medical, Inc. · 2024
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 6 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 5 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 4 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 3 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 2 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 1 generation backK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
- This deviceK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 29 · See all- K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023 · cites it directly11descendants
- K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated · 2023 · 2 generations on9descendants
- K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc. · 2023 · cites it directly4descendants
- K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine · 2025 · cites it directly3descendants
- K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc. · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −6 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −3 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| −2 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| −1 | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar… | Nu Vasive, Incorporated | 2021 | — |
| 0 (this device) | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | 2022 | — |
| +1 | K223731 | NuVasive Modulus-C Interbody System | Nuvasive, Inc. | 2023 | — |
| +2 | K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured… | Nu Vasive, Incorporated | 2023 | — |
| +1 | K231076 | VariLift®-C Interbody Fusion System | Wenzel Spine, Inc. | 2023 | — |
| +1 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System… | Alphatec Spine | 2025 | — |
| +2 | K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C… | Orthofix Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 12 | 0 |
| 2002 | 12 | 0 |
| 2003 | 17 | 0 |
| 2004 | 27 | 0 |
| 2005 | 21 | 0 |
| 2006 | 9 | 0 |
| 2007 | 16 | 0 |
| 2008 | 45 | 1 |
| 2009 | 29 | 0 |
| 2010 | 21 | 0 |
| 2011 | 27 | 0 |
| 2012 | 11 | 0 |
| 2013 | 16 | 0 |
| 2014 | 23 | 0 |
| 2015 | 17 | 0 |
| 2016 | 6 | 0 |
| 2017 | 9 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 13 | 0 |
| 2026 | 4 | 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.
1 device in this family has 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 ODP device
- #1 K222270 HEDRON Cervical Spacers, HEDRON Lumbar…score 41.4 · 25 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 |
|---|---|---|---|
| * | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Summary page 12…f 6 Review Panel: Orthopedic Product Codes: MQV E. Predicate Device Names Primary Predicate: DePuy Synthes Spine, K201605, EIT Cellular Cervical Cage, EIT Cellular ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellul… | 2020 |
| * | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Summary page 12…l Cage, EIT Cellular ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage Additional Predicate: Nuvasive Inc., K203714, NuVasive Thoracolumbar Interbody Systems and NuVasive Attrax Putty Additional Predicate: Prosidyan Inc., K170306, FIBERGRAFTTM… | 2021 |
| * | K170306 | FIBERGRAFT BG Putty Bone Graft SubstituteSummary page 12…nium T/PLIF Cage Additional Predicate: Nuvasive Inc., K203714, NuVasive Thoracolumbar Interbody Systems and NuVasive Attrax Putty Additional Predicate: Prosidyan Inc., K170306, FIBERGRAFTTM BG Putty Bone Graft Substitute F. Device Description The CONDUITTM Technology platform is a comprehensive po… | 2017 |
What descends from it? (29)
See all 2914 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223731 | NuVasive Modulus-C Interbody System | 2023 | 11 |
| K231076 | VariLift®-C Interbody Fusion System | 2023 | 4 |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi… | 2025 | 3 |
| K240458 | Synthetic Bone Putty | 2024 | 2 |
| K233490 | SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty | 2023 | 2 |
| K242299 | NovaBone Putty - Synthetic Bioactive Bone Graft | 2024 | 1 |
| K253147 | FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft… | 2025 | 0 |
| K250669 | Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology | 2025 | 0 |
| K250521 | NanoBone® SBX Putty ; NanoBone® QD | 2025 | 0 |
| K250556 | Porous Biologic Scaffold | 2025 | 0 |
Has anything in its family been recalled? (1 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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 39 of the 372 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K223731 (Nuvasive, Inc., 2023) has gone furthest, with 11 descendants of its own.
- 17 other devices also cite its predicate K201605.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The CONDUITTM Cervical Cages with a microscopic roughened surface and micro and nano-scale features are intervertebral body fusion devices intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - Tl. The…
Read the full statement (1,044 words)
The CONDUITTM Cervical Cages with a microscopic roughened surface and micro and nano-scale features are intervertebral body fusion devices intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - Tl. The CONDUITTM Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. CONDUITTM Cervical Cages are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.
The CONDUITTM ALIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S 1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
The CONDUITTM TLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S 1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
The CONDUITTM LLIF Cages with a microscopic roughened surface and micro and nano-scale features is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. CONDUITTM LLIF Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The CONDUITTM T/PLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S 1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
FIBERGRAFTTM BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFTTM BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFTTM BG Putty must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFTTM BG Putty must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
FIBERGRAFTTM BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
FIBERGRAFTTM BG Putty GPS - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFTTM BG Putty GPS is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFTTM BG Putty GPS must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFTTM BG Putty GPS must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
FIBERGRAFTTM BG Putty GPS is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
The GPS Cannula is intended for use only with FIBERGRAFTTM BG Putty GPS and no other products.
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/K222276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222276: CONDUIT Cages; FIBERGRAFT BG Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222276
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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