510(k) Report

510(k) · Cleared

Cleared

Biofastin RC Threaded Suture Anchor

K021883510(k) SpecialCleared Jul 1, 200224-day reviewClass II21 CFR 888.3040

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

Mitek Worldwide · HWC Screw, Fixation, Bone

Cleared on Jul 1, 2002 after a 24-day review. The FDA summary names its predicate without a number. 116 later devices descend from it.

Decided
Jul 1, 2002
Review
24 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 2 descendants cleared2005: 2 descendants cleared2007: 1 descendant cleared2009: 2 descendants cleared2006: 2 descendants cleared2010: 2 descendants cleared2023: 10 descendants cleared2011: 10 descendants cleared2012: 3 descendants cleared2008: 2 descendants cleared2013: 8 descendants cleared2019: 9 descendants cleared2017: 4 descendants cleared2025: 4 descendants cleared2014: 9 descendants cleared2021: 8 descendants cleared2020: 8 descendants cleared2015: 7 descendants cleared2022: 2 descendants cleared2016: 2 descendants cleared2018: 5 descendants cleared2026: 7 descendants cleared2024: 7 descendants cleared200020052010201520202025
  1. This deviceK021883 Biofastin RC Threaded Suture AnchorMitek Worldwide · 2002
  2. Descendant · cites it directly · 100 of its ownK041069 Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company · 2004 · Recalled
  3. Descendant · 2 generations on · 99 of its ownK071481 Healix AnchorDepuy Mitek, A Johnson & Johnson Company · 2007
  4. Descendant · 3 generations on · 50 of its ownK120449 Healix Advance Peek AnchorDepuy Mitek · 2012
  5. Descendant · 3 generations on · 44 of its ownK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
  6. Descendant · 4 generations on · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014

Showing 5 of 116 descendants. See all descendants

Descendants cleared per year

2004: 22005: 22006: 22007: 12008: 22009: 22010: 22011: 102012: 32013: 82014: 92015: 72016: 22017: 42018: 52019: 92020: 82021: 82022: 22023: 102024: 72025: 42026: 7
2004high 10 (2011) · low 1 (2007)2026

Most influential descendants

Showing 5 of 116 · See all
  • K041069Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company · 2004 · cites it directly100descendants
  • K071481Healix AnchorDepuy Mitek, A Johnson & Johnson Company · 2007 · 2 generations on99descendants
  • K120449Healix Advance Peek AnchorDepuy Mitek · 2012 · 3 generations on50descendants
  • K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · 3 generations on44descendants
  • K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · 4 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K021883Biofastin RC Threaded Suture AnchorMitek Worldwide2002—
+1K041069Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company200416
+2K071481Healix AnchorDepuy Mitek, A Johnson & Johnson Company2007—
+3K120449Healix Advance Peek AnchorDepuy Mitek2012—
+3K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company20081
+4K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200520
200620
200710
200820
200920
201020
2011100
201230
201380
201490
201570
201620
201740
201850
201990
202080
202180
202220
2023100
202470
202540
202670
FIG. 1 — Lineage of K021883, 2002–2026Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—FASTIN RC Suture Anchor
Named without a submission number
—
*—Mitek Cuff Tack Sutureless Fixation Device
Named without a submission number
—
*—PANALOK RC Absorbable Anchor
Named without a submission number
—

What descends from it? (116)

See all 116

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

NumberDeviceApplicantDecidedDescendants
K041069Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company2004100
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, K041069 (Depuy Mitek, A Johnson & Johnson Company, 2004) has gone furthest, with 100 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The BIOFASTIN RC Threaded Suture Anchor is indicated for shoulder rotator cuff repair.

Indications for use as stated in the FDA summary.

More from Mitek Worldwide

10 FDA decisions under this applicant name. See the company

  • K032717Biocryl Rapide Interference ScrewMitek Worldwide · 2004
  • K032167Bio-Intrafix Tibial Screw and SheathMitek Worldwide · 2003
  • K032078Mitek Micro QuickanchorMitek Worldwide · 2003
  • K030995Minilok Quickanchor PlusMitek Worldwide · 2003
  • K031519Cufflok AnchorMitek Worldwide · 2003

Recent decisions in HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
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  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K021883 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021883: Biofastin RC Threaded Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021883

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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