510(k) Report

510(k) · Cleared

Cleared

Microstrike and Allthread Peek Suture Anchor

K060693510(k) TraditionalCleared Jun 6, 200683-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

Arthrotek, Inc. · HWC Screw, Fixation, Bone

Cleared on Jun 6, 2006 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.

Decided
Jun 6, 2006
Review
83 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

27 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2014: 3 descendants cleared2016: 2 descendants cleared2008: 1 descendant cleared2007: 1 descendant cleared2011: 6 descendants cleared2020: 5 descendants cleared2013: 3 descendants cleared2015: 2 descendants cleared2023: 3 descendants cleared2018: 1 descendant cleared20052010201520202025
  1. This deviceK060693 Microstrike and Allthread Peek Suture AnchorArthrotek, Inc. · 2006
  2. Descendant · cites it directly · 9 of its ownK070389 Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · Recalled
  3. Descendant · cites it directly · 7 of its ownK133036 Apollo Suture Anchor System and Titan ScrewsAmendia, Inc. · 2014 · Recalled
  4. Descendant · 2 generations on · 7 of its ownK110230 Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011
  5. Descendant · cites it directly · 6 of its ownK110229 Rog Suture Anchor 5.5MM, 2.9MMRog Sports Medicine, Inc. · 2011
  6. Descendant · cites it directly · 6 of its ownK080088 Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · Recalled

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12011: 62013: 32014: 32015: 22016: 22018: 12020: 52023: 3
2007high 6 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 27 · See all
  • K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · cites it directly9descendants
  • K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc. · 2014 · cites it directly7descendants
  • K110230Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011 · 2 generations on7descendants
  • K110229Rog Suture Anchor 5.5MM, 2.9MMRog Sports Medicine, Inc. · 2011 · cites it directly6descendants
  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · cites it directly6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060693Microstrike and Allthread Peek Suture AnchorArthrotek, Inc.2006—
+1K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc.20071
+1K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.20141
+2K110230Rog Knotless Suture AnchorRog Sports Medicine, Inc.2011—
+1K110229Rog Suture Anchor 5.5MM, 2.9MMRog Sports Medicine, Inc.2011—
+1K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.20088

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201160
201330
201430
201520
201620
201810
202050
202330
FIG. 1 — Lineage of K060693, 2006–2023Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc.20079
K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.20147
K110229Rog Suture Anchor 5.5MM, 2.9MMRog Sports Medicine, Inc.20116
K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.20086
K193402ALLthread PEEK Suture AnchorBiomet, Inc.20200
K153558Ventix Suture AnchorBiomet Manufacturing Corp20160

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, K070389 (Biomet Sports Medicine, Inc., 2007) has gone furthest, with 9 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—

More from Arthrotek, Inc.

17 FDA decisions under this applicant name. See the company

  • K061776Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc. · 2006
  • K0618012.8 & 3.5MM Lactoscrew Suture AnchorsArthrotek, Inc. · 2006
  • K061657Hitch Lactosorb Suture AnchorArthrotek, Inc. · 2006
  • K061389Allthread Lactosorb Suture AnchorArthrotek, Inc. · 2006
  • K053461Ezloc Femoral Fixation DeviceArthrotek, Inc. · 2006

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/K060693 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060693: Microstrike and Allthread Peek 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/K060693

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026