510(k) Report

510(k) · Cleared

Cleared

Paralock Plating System / Tuffnek Screw

K140397510(k) TraditionalCleared Apr 17, 201458-day reviewClass II21 CFR 888.3030

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

Paragon 28 · HRS Plate, Fixation, Bone

Cleared on Apr 17, 2014 as substantially equivalent to K011118 (Osteomedics, 2001) and 18 other predicates after a 58-day review. Its family tree reaches back 12 generations to 1996. 31 later devices descend from it.

Decided
Apr 17, 2014
Review
58 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
19

Its longest line of descent runs back 12 generations to K954385 (1996). 182 ancestors in all, the oldest K792022 (1979). 31 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 4 other ancestors2011: 5 other ancestors2010: 9 other ancestors2009: 10 other ancestors2007: 5 other ancestors2005: 15 other ancestors2004: 7 other ancestors2003: 6 other ancestors2002: 17 other ancestors2001: 16 other ancestors1993: 2 other ancestors2008: 7 other ancestors2006: 14 other ancestors2000: 13 other ancestors1996: 10 other ancestors1999: 5 other ancestors1995: 4 other ancestors1994: 5 other ancestors1991: 1 other ancestor1989: 1 other ancestor1998: 6 other ancestors1992: 2 other ancestors1990: 3 other ancestors1979: 1 other ancestor1997: 2 other ancestors2017: 5 descendants cleared2023: 4 descendants cleared2018: 2 descendants cleared2019: 4 descendants cleared2021: 4 descendants cleared2020: 5 descendants cleared2026: 2 descendants cleared2025: 1 descendant cleared2022: 1 descendant cleared2024: 3 descendants clearedK954385 · Synthes Mandibular Modular Fixation System · Synthes (Usa) · 1996K974555 · Synthes 2.0 MM Locking Plate System (2.0 LPS) · Synthes (Usa) · 1998×2: 2 generations cleared close together, K030448 (2003), K032442 (2003) K040598 · KLS Martin Hand Plating System · KLS-Martin L.P. · 2004K050868 · Maxlock · Orthohelix Surgical Designs, Inc. · 2005K073624 · Modular Foot System · Orthohelix Surgical Designs, Inc. · 2008 · recalled×2: 2 generations cleared close together, K100618 (2010), K102156 (2010) K111041 · Mini Variable System · Orthohelix Surgical Designs, Inc. · 2011×2: 2 generations cleared close together, K120157 (2012), K121437 (2012) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 17 other ancestors2 generations back: 22 other ancestors3 generations back: 36 other ancestors4 generations back: 23 other ancestors5 generations back: 20 other ancestors6 generations back: 18 other ancestors7 generations back: 18 other ancestors8 generations back: 9 other ancestors9 generations back: 3 other ancestors10 generations back: 2 other ancestors11 generations back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 6 descendants3 generations forward: 8 descendants4 generations forward: 5 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant K121437 · Mini Maxlock Extreme Plating System · Orthohelix Surgical Designs, Inc. · 2012K120157 · Mini Maxlock Extreme Plating System · Orthohelix Surgical Designs, Inc. · 2012K111041 · Mini Variable System · Orthohelix Surgical Designs, Inc. · 2011K102156 · Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws · Orthohelix Surgical Designs, Inc. · 2010 · recalledK100618 · Maxlock Extreme Extremity Plating System with Variable Angle Technology · Orthohelix Surgical Designs, Inc. · 2010K073624 · Modular Foot System · Orthohelix Surgical Designs, Inc. · 2008 · recalledK050868 · Maxlock · Orthohelix Surgical Designs, Inc. · 2005K040598 · KLS Martin Hand Plating System · KLS-Martin L.P. · 2004K032442 · KLS-Martin Mandibular/Reconstruction System II · KLS-Martin L.P. · 2003K030448 · Osteomed 2.0 Locking Plates and Screws · Osteomed LP · 2003K974555 · Synthes 2.0 MM Locking Plate System (2.0 LPS) · Synthes (Usa) · 1998K954385 · Synthes Mandibular Modular Fixation System · Synthes (Usa) · 1996−10−50+5
  1. Root · 12 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
  2. 8 generations between
  3. 3 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
  4. 2 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
  5. 1 generation backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
  6. This deviceK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  7. Descendant · cites it directly · 9 of its ownK170693 Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
  8. Descendant · 2 generations on · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
  9. Descendant · cites it directly · 8 of its ownK170214 Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017
  10. Descendant · 3 generations on · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020
  11. Descendant · 3 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
Show all 12 generations
  1. Root · 12 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
  2. 11 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
  3. 10 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
  4. 9 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
  5. 8 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
  6. 7 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
  7. 6 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
  8. 5 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
  9. 4 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
  10. 3 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
  11. 2 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
  12. 1 generation backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
  13. This deviceK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2017: 52018: 22019: 42020: 52021: 42022: 12023: 42024: 32025: 12026: 2
2017high 5 (2017) · low 1 (2022)2026

Most influential descendants

Showing 5 of 31 · See all
  • K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017 · cites it directly9descendants
  • K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · 2 generations on8descendants
  • K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017 · cites it directly8descendants
  • K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020 · 3 generations on6descendants
  • K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K954385Synthes Mandibular Modular Fixation SystemSynthes (Usa)1996—
−11K974555Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa)1998—
−10K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP2003—
−9K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P.2003—
−8K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004—
−7K050868MaxlockOrthohelix Surgical Designs, Inc.2005—
−6K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20081
−5K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010—
−4K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101
−3K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.2011—
−2K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2012—
−1K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2012—
0 (this device)K140397Paralock Plating System / Tuffnek ScrewParagon 282014—
+1K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.2017—
+2K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary…Paragon 28, Inc.2019—
+1K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC2017—
+3K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.2020—
+3K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198910
199030
199110
199220
199320
199450
199540
1996100
199720
199860
199950
2000130
2001160
2002170
200360
200470
2005150
2006140
200750
200870
2009100
201090
201150
201240

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201750
201820
201940
202050
202140
202210
202340
202430
202510
202620
FIG. 1 — Lineage of K140397, 1996–2026Source: 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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
*K011118Normed Extremity Titanium Hand and Small Fragment System
Summary page 1
…Normed Titanium Calcaneus Plating with Locking Screw System and the Normed Titanium Osteotomy Plating System (Osteomedics Inc - K01 1118, K022324 and K022325, respectively) . The Wright Medical ORTHOLOC Tm 3…
Osteomedics2001—
*K022324Normed Titanium Calcaneus Plating with Locking Screw System
Summary page 1
…ing with Locking Screw System and the Normed Titanium Osteotomy Plating System (Osteomedics Inc - K01 1118, K022324 and K022325, respectively) . The Wright Medical ORTHOLOC Tm 3Di Hallux System, The Wright Medical…
Osteomedics, Inc.20021
*K022325Normed Titanium Osteotomy Plating System
Summary page 1
…king Screw System and the Normed Titanium Osteotomy Plating System (Osteomedics Inc - K01 1118, K022324 and K022325, respectively) . The Wright Medical ORTHOLOC Tm 3Di Hallux System, The Wright Medical…
Osteomedics, Inc.20021
*K120359Ortholoc 3DI Hallux System
Summary page 1
…ng System and The Wright Medical ORTHOLOC Tm 30i MidfootlFlatfoot System (Wright Medical Technology, Inc. - K120359, K121425 and K121651, respectively) , CHARLOTTE T M Snap-Off Screw (Wright Medical Technology, Inc.…
Wrightmedicaltechnologyinc20122
*K121425Ortholoc 3DI Ankle Fusion Plating System
Summary page 1
…and The Wright Medical ORTHOLOC Tm 30i MidfootlFlatfoot System (Wright Medical Technology, Inc. - K120359, K121425 and K121651, respectively) , CHARLOTTE T M Snap-Off Screw (Wright Medical Technology, Inc.…
Wrightmedicaltechnologyinc2012—
*K121651Ortholoc 3DI Midfoot/Flatfoot System
Summary page 1
…ght Medical ORTHOLOC Tm 30i MidfootlFlatfoot System (Wright Medical Technology, Inc. - K120359, K121425 and K121651, respectively) , CHARLOTTE T M Snap-Off Screw (Wright Medical Technology, Inc.…
Wrightmedicaltechnologyinc2012—
*K043583Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003
Summary page 1
…- K120359, K121425 and K121651, respectively) , CHARLOTTE T M Snap-Off Screw (Wright Medical Technology, Inc. K043583, K050819) * M3-X Extremity Fixation (OsteoMed Corp., K92401 8) * The Arth…
Wrightmedicaltechnologyinc2005—
*K050819Charlotte Snap-Off Screw
Summary page 1
…9, K121425 and K121651, respectively) , CHARLOTTE T M Snap-Off Screw (Wright Medical Technology, Inc. K043583, K050819) * M3-X Extremity Fixation (OsteoMed Corp., K92401 8) * The Arthrex Titan…
Wrightmedicaltechnologyinc2005—
*K924018M3 Lag Screw Fixation System
Summary page 1
…M Snap-Off Screw (Wright Medical Technology, Inc. K043583, K050819) * M3-X Extremity Fixation (OsteoMed Corp., K92401 8) * The Arthrex Titanium Opening Wedge Osteotomy System, the Arthrex Sm…
Osteomed Corp.1993—
*K032187Anthrex Titanium Opening Wedge Osteotomy System
Summary page 1
…Screw System, the Arthrex Low Profile Screws and The Arthrex Distal Extremity Plate System (Arthrex, Inc. - K0321 87, K040907, K052614. K103705 and K1 11253, respectively)…
Arthrex, Inc.20031
*K040907Arthrex Small Fragment Plates and Screws
Summary page 1
…em, the Arthrex Low Profile Screws and The Arthrex Distal Extremity Plate System (Arthrex, Inc. - K0321 87, K040907, K052614. K103705 and K1 11253, respectively)…
Arthrex, Inc.2004—
*K052614Low Profile Plate and Screw System
Summary page 1
…the Arthrex Low Profile Screws and The Arthrex Distal Extremity Plate System (Arthrex, Inc. - K0321 87, K040907, K052614. K103705 and K1 11253, respectively)…
Arthrex, Inc.2005—
*K103705Low Profile Screws
Summary page 1
…the Arthrex Low Profile Screws and The Arthrex Distal Extremity Plate System (Arthrex, Inc. - K0321 87, K040907, K052614. K103705 and K1 11253, respectively)…
Arthrex, Inc.2011—
*K111253Arthrex Distal Extremity Plate System
Summary page 1
…rews and The Arthrex Distal Extremity Plate System (Arthrex, Inc. - K0321 87, K040907, K052614. K103705 and K1 11253, respectively) K140397 page 2 of 2…
Arthrex, Inc.2011—
*K063875Stryker Foot Plating System
Summary page 2
…2 === K140397 page 2 of 2 * The StrykerO Foot Plating System (Howmedica Osteonics - K063875) * The Mini Maxt-ock Extreme® Plating System (OrthoHelix Surgical Designs Inc. - K10196…
Howmedica Osteonics Corp.2007—
*K101962Mini Maxlock Extreme Plating System
Summary page 2
…Plating System (Howmedica Osteonics - K063875) * The Mini Maxt-ock Extreme® Plating System (OrthoHelix Surgical Designs Inc. - K101962, K120157 & K121437) * OsteoMed Foot Plating System ("FPS" OsteoMed LP - K091614) Performance Data: Mechanic…
Orthohelix Surgical Designs, Inc.20101
*K120157Mini Maxlock Extreme Plating System
Summary page 2
…System (Howmedica Osteonics - K063875) * The Mini Maxt-ock Extreme® Plating System (OrthoHelix Surgical Designs Inc. - K101962, K120157 & K121437) * OsteoMed Foot Plating System ("FPS" OsteoMed LP - K091614) Performance Data: Mechanical testin…
Orthohelix Surgical Designs, Inc.2012—
*K121437Mini Maxlock Extreme Plating System
Summary page 2
…wmedica Osteonics - K063875) * The Mini Maxt-ock Extreme® Plating System (OrthoHelix Surgical Designs Inc. - K101962, K120157 & K121437) * OsteoMed Foot Plating System ("FPS" OsteoMed LP - K091614) Performance Data: Mechanical testing of the w…
Orthohelix Surgical Designs, Inc.2012—
*K091614Osteomed Foot Plating System
Summary page 2
…ting System (OrthoHelix Surgical Designs Inc. - K101962, K120157 & K121437) * OsteoMed Foot Plating System ("FPS" OsteoMed LP - K091614) Performance Data: Mechanical testing of the worst case ParaL-ock Plates included static and dynamic bendin…
Osteomed LP2009—

Also cleared against K011118: 1 other device →

What descends from it? (31)

See all 31

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

NumberDeviceApplicantDecidedDescendants
K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179
K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178
K172886Breakaway Screw SystemParagon 2820174
K172260Omni Foot Plating SystemExtremity Medical, LLC20174
K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183
K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230
K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170

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 18 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
  • 43 of the 182 ancestors have a recall of any class.
  • Of its descendants, K170693 (Paragon 28, Inc., 2017) has gone furthest, with 9 descendants of its own.
  • 1 other device also cites its predicate K011118.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The ParaLock Bone Plates and TUFFNEK Bone Screws of the ParaLock Plating System are indicated for use In stabilization and fixation of fractures or osteotomies: intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles Including the distal tibia, talus, and calcaneus. The system can be used In both adult and pediatric patients.…

Read the full statement (103 words)

The ParaLock Bone Plates and TUFFNEK Bone Screws of the ParaLock Plating System are indicated for use In stabilization and fixation of fractures or osteotomies: intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles Including the distal tibia, talus, and calcaneus. The system can be used In both adult and pediatric patients.

In addition, the TUFFNEK non-locking, titanium alloy (Ti6AI4V ELI) screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.

Indications for use as stated in the FDA summary.

Also cleared against K011118

1 other device cites the same predicate.

  • K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004

More from Paragon 28

7 FDA decisions under this applicant name. See the company

  • K171715HammerTube SystemParagon 28 · 20181 recall
  • K172886Breakaway Screw SystemParagon 28 · 2017
  • K170923JAWS (TM) Nitinol Staple SystemParagon 28 · 20171 recall
  • K162241TITAN 3-D™ Wedge SystemParagon 28 · 20171 recall
  • K153378Monster BITE Screw SystemParagon 28 · 2015

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K140397 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140397: Paralock Plating System / Tuffnek Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140397

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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