510(k) Report

510(k) · Cleared

Cleared

Bio-Fastak Suture Anchor, Model AR-1324B

K000506510(k) TraditionalCleared May 1, 200076-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 May 1, 2000 after a 76-day review. The FDA summary names no predicate by number. 186 later devices descend from it.

Decided
May 1, 2000
Review
76 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
0

186 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2005: 2 descendants cleared2014: 10 descendants cleared2010: 9 descendants cleared2011: 11 descendants cleared2006: 4 descendants cleared2017: 9 descendants cleared2009: 11 descendants cleared2012: 10 descendants cleared2019: 7 descendants cleared2018: 8 descendants cleared2021: 6 descendants cleared2008: 3 descendants cleared2020: 10 descendants cleared2023: 19 descendants cleared2013: 11 descendants cleared2025: 13 descendants cleared2015: 13 descendants cleared2016: 3 descendants cleared2024: 11 descendants cleared2022: 5 descendants cleared2026: 9 descendants cleared200020052010201520202025
  1. This deviceK000506 Bio-Fastak Suture Anchor, Model AR-1324BArthrex, Inc. · 2000
  2. Descendant · cites it directly · 151 of its ownK051219 PushlockArthrex, Inc. · 2005
  3. Descendant · 2 generations on · 64 of its ownK073509 Twinfix PK FP Suture AnchorSmith & Nephew, Inc. · 2008
  4. Descendant · 2 generations on · 50 of its ownK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
  5. Descendant · 3 generations on · 41 of its ownK093428 Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009
  6. Descendant · cites it directly · 35 of its ownK070882 Stryker Peek Twinloop TacStryker Endoscopy · 2007

Showing 5 of 186 descendants. See all descendants

Descendants cleared per year

2005: 22006: 42007: 22008: 32009: 112010: 92011: 112012: 102013: 112014: 102015: 132016: 32017: 92018: 82019: 72020: 102021: 62022: 52023: 192024: 112025: 132026: 9
2005high 19 (2023) · low 2 (2005)2026

Most influential descendants

Showing 5 of 186 · See all
  • K051219PushlockArthrex, Inc. · 2005 · cites it directly151descendants
  • K073509Twinfix PK FP Suture AnchorSmith & Nephew, Inc. · 2008 · 2 generations on64descendants
  • K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006 · 2 generations on50descendants
  • K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009 · 3 generations on41descendants
  • K070882Stryker Peek Twinloop TacStryker Endoscopy · 2007 · cites it directly35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000506Bio-Fastak Suture Anchor, Model AR-1324BArthrex, Inc.2000—
+1K051219PushlockArthrex, Inc.2005—
+2K073509Twinfix PK FP Suture AnchorSmith & Nephew, Inc.2008—
+2K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp.2006—
+3K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc.2009—
+1K070882Stryker Peek Twinloop TacStryker Endoscopy2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200640
200720
200830
2009110
201090
2011110
2012100
2013110
2014100
2015130
201630
201790
201880
201970
2020100
202160
202250
2023190
2024110
2025130
202690
FIG. 1 — Lineage of K000506, 2000–2026Source: 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 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?

The FDA summary names no predicate by number.

What descends from it? (186)

See all 186

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

NumberDeviceApplicantDecidedDescendants
K051219PushlockArthrex, Inc.2005151
K070882Stryker Peek Twinloop TacStryker Endoscopy200735
K051983Model 3000 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, K051219 (Arthrex, Inc., 2005) has gone furthest, with 151 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—

What is it indicated for?

The Bio-Fastak is intended for fixation of suture 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…

Read the full statement (115 words)

The Bio-Fastak is intended for fixation of suture 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

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

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

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

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  • 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/K000506 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000506: Bio-Fastak Suture Anchor, Model AR-1324B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000506

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026