510(k) Report

510(k) · Cleared

Recalled · 2005

Fastin RC Anchor

K041075510(k) TraditionalCleared Nov 9, 2004197-day reviewClass II21 CFR 888.3040Recalls 1

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

Depuy Mitek, A Johnson & Johnson Company · HWC Screw, Fixation, Bone

Cleared on Nov 9, 2004 as substantially equivalent to K983818 (Mitek Products, 1998) after a 197-day review. Its family tree reaches back 1 generation to 1998. 22 later devices descend from it. It has been recalled once.

Decided
Nov 9, 2004
Review
197 days
Class
Class II
Product code
HWC
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K983818 (1998). 22 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2011: 4 descendants cleared2014: 3 descendants cleared2019: 1 descendant cleared2021: 2 descendants cleared2025: 1 descendant cleared2012: 1 descendant cleared2013: 2 descendants cleared2023: 2 descendants cleared2024: 1 descendant cleared2022: 1 descendant cleared2026: 2 descendants cleared2018: 1 descendant clearedReference device: K040004 · Orthocord Suture · Depuy Mitek · 2004 · recalledK983818 · Mitek Fastin RC Anchor · Mitek Products · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 5 descendants4 generations forward: 11 descendants5 generations forward: 1 descendant K983818 · Mitek Fastin RC Anchor · Mitek Products · 19980+5
  1. Root · 1 generation backK983818 Mitek Fastin RC AnchorMitek Products · 1998
  2. This deviceK041075 Fastin RC AnchorDepuy Mitek, A Johnson & Johnson Company · 2004
  3. Descendant · cites it directly · 21 of its ownK082282 Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008
  4. Descendant · 2 generations on · 15 of its ownK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
  5. Descendant · 3 generations on · 6 of its ownK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · Recalled
  6. Descendant · 3 generations on · 6 of its ownK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
  7. Descendant · 4 generations on · 3 of its ownK222091 Grappler Suture Anchor SystemParagon 28, Inc. · 2022

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2008: 12011: 42012: 12013: 22014: 32018: 12019: 12021: 22022: 12023: 22024: 12025: 12026: 2
2008high 4 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 22 · See all
  • K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008 · cites it directly21descendants
  • K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company · 2011 · 2 generations on15descendants
  • K211002Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · 3 generations on6descendants
  • K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011 · 3 generations on6descendants
  • K222091Grappler Suture Anchor SystemParagon 28, Inc. · 2022 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K983818Mitek Fastin RC AnchorMitek Products1998—
0 (this device)K041075Fastin RC AnchorDepuy Mitek, A Johnson & Johnson Company2004—
+1K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co.2008—
+2K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend…Depuy Mitek, A Johnson & Johnson Company2011—
+3K211002Grappler Suture Anchor SystemParagon 28, Inc.20211
+3K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company2011—
+4K222091Grappler Suture Anchor SystemParagon 28, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201140
201210
201320
201430
201810
201910
202120
202210
202320
202410
202510
202620
FIG. 1 — Lineage of K041075, 1998–2026Source: 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? (1)

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
*K983818Mitek Fastin RC Anchor
Summary page 2
…Mitek believes that the Fastin RC Anchor is substantially equivalent to Mitek's existing Fastin RC Anchor (K983818). A statement of substantial equivalence is provided in Section 3 and the…
Mitek Products1998—
†K040004Orthocord SutureDepuy Mitek20041

Also cleared against K983818: 1 other device →

What descends from it? (22)

See all 22

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co.200821

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 27, 2005Not classifiedZ-0446-06OtherThe device may contain one strand of suture instead of two strands

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K082282 (Depuy Mitek, A Johnson & Johnson Co., 2008) has gone furthest, with 21 descendants of its own.
  • 1 other device also cites its predicate K983818.

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 Fastin RC Anchors are intended for:

Shoulder: Rotator cuff repair.

Indications for use as stated in the FDA summary.

Also cleared against K983818

1 other device cites the same predicate.

  • K011912Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000Axya Medical, Inc. · 2001

More from Depuy Mitek, A Johnson & Johnson Company

58 FDA decisions under this applicant name. See the company

  • K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2015
  • K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3…Depuy Mitek, A Johnson & Johnson Company · 2014
  • K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company · 2014
  • K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek Anchor with Permacord…Depuy Mitek, A Johnson & Johnson Company · 2014
  • K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix Advance BR Anchor…Depuy Mitek, A Johnson & Johnson Company · 2014

Recent decisions in HWC

The HWC category page

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  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K041075 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041075: Fastin RC Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041075

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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