510(k) Report

510(k) · Cleared

Cleared

Bio-Absorbable Corkscrew Model AR-1920B

K003227510(k) TraditionalCleared Jan 8, 200184-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

Arthrex, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Jan 8, 2001 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 526 later devices descend from it.

Decided
Jan 8, 2001
Review
84 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
0

526 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2004: 3 descendants cleared2005: 3 descendants cleared2006: 7 descendants cleared2002: 1 descendant cleared2003: 1 descendant cleared2009: 13 descendants cleared2007: 8 descendants cleared2017: 25 descendants cleared2024: 40 descendants cleared2016: 12 descendants cleared2011: 24 descendants cleared2018: 30 descendants cleared2022: 31 descendants cleared2008: 8 descendants cleared2014: 29 descendants cleared2023: 46 descendants cleared2019: 39 descendants cleared2013: 18 descendants cleared2012: 12 descendants cleared2010: 8 descendants cleared2021: 25 descendants cleared2015: 18 descendants cleared2025: 44 descendants cleared2020: 36 descendants cleared2026: 45 descendants cleared200020052010201520202025
  1. This deviceK003227 Bio-Absorbable Corkscrew Model AR-1920BArthrex, Inc. · 2001
  2. Descendant · cites it directly · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
  3. Descendant · cites it directly · 145 of its ownK043337 Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc. · 2004
  4. Descendant · 2 generations on · 114 of its ownK061665 Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc. · 2006
  5. Descendant · cites it directly · 103 of its ownK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
  6. Descendant · cites it directly · 100 of its ownK060271 Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company · 2006 · Recalled

Showing 5 of 526 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 32005: 32006: 72007: 82008: 82009: 132010: 82011: 242012: 122013: 182014: 292015: 182016: 122017: 252018: 302019: 392020: 362021: 252022: 312023: 462024: 402025: 442026: 45
2002high 46 (2023) · low 1 (2002)2026

Most influential descendants

Showing 5 of 526 · See all
  • K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · cites it directly217descendants
  • K043337Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc. · 2004 · cites it directly145descendants
  • K061665Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc. · 2006 · 2 generations on114descendants
  • K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006 · cites it directly103descendants
  • K060271Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company · 2006 · cites it directly100descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003227Bio-Absorbable Corkscrew Model AR-1920BArthrex, Inc.2001—
+1K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…Arthrex, Inc.2005—
+1K043337Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc.2004—
+2K061665Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc.2006—
+1K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company2006—
+1K060271Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company200616

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200430
200530
200670
200780
200880
2009130
201080
2011240
2012120
2013180
2014290
2015180
2016120
2017250
2018300
2019390
2020360
2021250
2022310
2023460
2024400
2025440
2026450
FIG. 1 — Lineage of K003227, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MAI? 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 MAI device

  1. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (526)

See all 526

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

NumberDeviceApplicantDecidedDescendants
K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217
K043337Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc.2004145
K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company2006103
K060271Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company2006100
K020056Duet Suture AnchorBionx Implants, Ltd.200278
K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377
K041698Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc.200414
K051250Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc.200511

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?

  • Of its descendants, K052776 (Arthrex, Inc., 2005) has gone furthest, with 217 descendants of its own.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
2007high 40 (2020) · low 0 (2007)2026

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

Adverse event reports per year · MAI

2,148in 2025

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, 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
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

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355 FDA decisions under this applicant name. See the company

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  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026

Recent decisions in MAI

The MAI category page

  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K003227 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003227: Bio-Absorbable Corkscrew Model AR-1920B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003227

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026