510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Spiralok Anchor

K041069510(k) TraditionalCleared Nov 9, 2004197-day reviewClass II21 CFR 888.3040Recalls 16

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 K021883 (Mitek Worldwide, 2002) after a 197-day review. Its family tree reaches back 1 generation to 2002. 100 later devices descend from it. It has been recalled 16 times.

Decided
Nov 9, 2004
Review
197 days
Class
Class II
Product code
HWC
Recalls
16
Predicates
1

Its longest line of descent runs back 1 generation to K021883 (2002). 100 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2011: 9 descendants cleared2012: 3 descendants cleared2008: 2 descendants cleared2019: 9 descendants cleared2009: 1 descendant cleared2017: 4 descendants cleared2010: 1 descendant cleared2025: 4 descendants cleared2014: 8 descendants cleared2021: 8 descendants cleared2013: 6 descendants cleared2020: 7 descendants cleared2022: 2 descendants cleared2023: 9 descendants cleared2015: 6 descendants cleared2016: 2 descendants cleared2018: 5 descendants cleared2024: 7 descendants cleared2026: 6 descendants clearedReference device: K040004 · Orthocord Suture · Depuy Mitek · 2004 · recalledK021883 · Biofastin RC Threaded Suture Anchor · Mitek Worldwide · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 23 descendants4 generations forward: 31 descendants5 generations forward: 19 descendants6 generations forward: 5 descendants7 generations forward: 7 descendants8 generations forward: 4 descendants9 generations forward: 4 descendants K021883 · Biofastin RC Threaded Suture Anchor · Mitek Worldwide · 20020+5
  1. Root · 1 generation backK021883 Biofastin RC Threaded Suture AnchorMitek Worldwide · 2002
  2. This deviceK041069 Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company · 2004
  3. Descendant · cites it directly · 99 of its ownK071481 Healix AnchorDepuy Mitek, A Johnson & Johnson Company · 2007
  4. Descendant · 2 generations on · 50 of its ownK120449 Healix Advance Peek AnchorDepuy Mitek · 2012
  5. Descendant · 2 generations on · 44 of its ownK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
  6. Descendant · 3 generations on · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
  7. Descendant · 3 generations on · 25 of its ownK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled

Showing 5 of 100 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 12010: 12011: 92012: 32013: 62014: 82015: 62016: 22017: 42018: 52019: 92020: 72021: 82022: 22023: 92024: 72025: 42026: 6
2007high 9 (2011) · low 1 (2007)2026

Most influential descendants

Showing 5 of 100 · See all
  • K071481Healix AnchorDepuy Mitek, A Johnson & Johnson Company · 2007 · cites it directly99descendants
  • K120449Healix Advance Peek AnchorDepuy Mitek · 2012 · 2 generations on50descendants
  • K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · 2 generations on44descendants
  • K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · 3 generations on31descendants
  • K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company · 2009 · 3 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K021883Biofastin RC Threaded Suture AnchorMitek Worldwide2002—
0 (this device)K041069Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company2004—
+1K071481Healix AnchorDepuy Mitek, A Johnson & Johnson Company2007—
+2K120449Healix Advance Peek AnchorDepuy Mitek2012—
+2K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company20081
+3K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC2014—
+3K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model…Depuy Mitek, A Johnson & Johnson Company20092

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200910
201010
201190
201230
201360
201480
201560
201620
201740
201850
201990
202070
202180
202220
202390
202470
202540
202660
FIG. 1 — Lineage of K041069, 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? (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
*K021883Biofastin RC Threaded Suture Anchor
Summary page 2
…Mitek believes that the Spiralok Anchor is substantially equivalent to Mitek's BioFastin RC Anchor (K021883). A statement of substantial equivalence is provided in Section 3 and the…
Mitek Worldwide2002—
†K040004Orthocord SutureDepuy Mitek20041

Also cleared against K021883: 2 other devices →

What descends from it? (100)

See all 100

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

NumberDeviceApplicantDecidedDescendants
K071481Healix AnchorDepuy Mitek, A Johnson & Johnson Company200799

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 6, 2012Class IIZ-0140-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0152-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0143-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0145-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0146-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0148-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0149-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0142-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0151-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0154-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0141-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0144-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0147-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0150-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0153-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision
Sep 6, 2012Class IIZ-0155-2013Device DesignFracture of SPIRALOK Anchors post op, requiring patient revision

The 5 latest of 16 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K071481 (Depuy Mitek, A Johnson & Johnson Company, 2007) has gone furthest, with 99 descendants of its own.
  • 2 other devices also cite its predicate K021883.

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 Spiralok Anchor is intended for:

Shoulder: Rotator cuff repair.

Indications for use as stated in the FDA summary.

Also cleared against K021883

2 other devices cite the same predicate.

  • K051250Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2005
  • K041698Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2004

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

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The HWC category page

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https://510kreport.com/device/K041069 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041069: Spiralok Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041069

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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