510(k) Report

510(k) · Cleared

Cleared

Headed Bio-Absorbable Corkscrew Model #AR-1921BU

K990361510(k) TraditionalCleared Apr 14, 199968-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 Apr 14, 1999 as substantially equivalent to K971723 (Arthrex, Inc., 1997) after a 68-day review. Its family tree reaches back 1 generation to 1997. 79 later devices descend from it.

Decided
Apr 14, 1999
Review
68 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K971723 (1997). 79 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2009: 6 descendants cleared2008: 1 descendant cleared2010: 3 descendants cleared2011: 3 descendants cleared2017: 7 descendants cleared2018: 4 descendants cleared2023: 8 descendants cleared2012: 2 descendants cleared2013: 3 descendants cleared2019: 6 descendants cleared2026: 2 descendants cleared2020: 5 descendants cleared2016: 1 descendant cleared2014: 3 descendants cleared2015: 2 descendants cleared2022: 4 descendants cleared2021: 4 descendants cleared2025: 8 descendants cleared2024: 3 descendants clearedK971723 · Fastak Suture Anchor (11.7MM)/(7.5MM) · Arthrex, Inc. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 7 descendants4 generations forward: 14 descendants5 generations forward: 15 descendants6 generations forward: 21 descendants7 generations forward: 12 descendants8 generations forward: 6 descendants K971723 · Fastak Suture Anchor (11.7MM)/(7.5MM) · Arthrex, Inc. · 19970+5
  1. Root · 1 generation backK971723 Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc. · 1997
  2. This deviceK990361 Headed Bio-Absorbable Corkscrew Model #AR-1921BUArthrex, Inc. · 1999
  3. Descendant · cites it directly · 78 of its ownK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
  4. Descendant · cites it directly · 77 of its ownK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
  5. Descendant · 2 generations on · 76 of its ownK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
  6. Descendant · 2 generations on · 75 of its ownK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
  7. Descendant · 3 generations on · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 12006: 12008: 12009: 62010: 32011: 32012: 22013: 32014: 32015: 22016: 12017: 72018: 42019: 62020: 52021: 42022: 42023: 82024: 32025: 82026: 2
2002high 8 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 79 · See all
  • K020056Duet Suture AnchorBionx Implants, Ltd. · 2002 · cites it directly78descendants
  • K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003 · cites it directly77descendants
  • K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd. · 2004 · 2 generations on76descendants
  • K053561Bio-Mini Revo Suture AnchorConmed Linvatec · 2006 · 2 generations on75descendants
  • K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · 3 generations on56descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971723Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc.1997—
0 (this device)K990361Headed Bio-Absorbable Corkscrew Model #AR-1921BUArthrex, Inc.1999—
+1K020056Duet Suture AnchorBionx Implants, Ltd.2002—
+1K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.2003—
+2K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models…Linvatec Biomaterials, Ltd.2004—
+2K053561Bio-Mini Revo Suture AnchorConmed Linvatec2006—
+3K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.20091

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200410
200610
200810
200960
201030
201130
201220
201330
201430
201520
201610
201770
201840
201960
202050
202140
202240
202380
202430
202580
202620
FIG. 1 — Lineage of K990361, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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
Get a 510(k) Report

What was it cleared against? (4)

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
*K971723Fastak Suture Anchor (11.7MM)/(7.5MM)
Summary page 3
…5.0mm Screwin | 79.3 lbs.* Absorbable fixation Corkscrew Arthrex FASTak Soft tissue to bone | Titanium Alloy 2.4mm Screwin | 55.40 [bs.* fixation #2 suture As reported: K971723 Zimmer Bio-Statak Soft tissue to bone | Poly (L-lactic) acid | 5.0mm Screw in | Diaphyseal: 69 1bs.** (RSTA) fixation #2 suture M…
Arthrex, Inc.1997—
*—Zimmer Bio-Statak (RSTA)
Named without a submission number
—
*—Linvatec Bio-Anchor
Named without a submission number
—
*—Ethicon Mitek 3.5mm Panalok Wedge Absorbable Suture Anchor
Named without a submission number
—

Also cleared against K971723: 6 other devices →

What descends from it? (79)

See all 79

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

NumberDeviceApplicantDecidedDescendants
K020056Duet Suture AnchorBionx Implants, Ltd.200278
K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377

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?

  • Its one ancestor has no recall.
  • Of its descendants, K020056 (Bionx Implants, Ltd., 2002) has gone furthest, with 78 descendants of its own.
  • 6 other devices also cite its predicate K971723.

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—

What is it indicated for?

The Headed Bio-Absorbable Corkscrew is intended for fixation of soft tissue to bone. This product is intended for the following indications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot…

Read the full statement (102 words)

The Headed Bio-Absorbable Corkscrew is intended for fixation of soft tissue to bone.

This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps

Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift

or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,

Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament

Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,

Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band

Tenodesis

Hand/Wrist. Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament

Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial

Collateral Ligamant Reconstruction

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K971723

6 other devices cite the same predicate.

  • K082729Rimclose Bone AnchorAnulex Technologies, Inc. · 2008
  • K072063KFX Tissue Fixation System and AccessoriesKfx Medical · 2007
  • K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
  • K070882Stryker Peek Twinloop TacStryker Endoscopy · 2007
  • K051219PushlockArthrex, Inc. · 2005
  • K050358Artherx Corkscrew FT II Suture AnchorArthrex, Inc. · 2005

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • 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/K990361 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990361: Headed Bio-Absorbable Corkscrew Model #AR-1921BU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990361

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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