510(k) Report

510(k) · Cleared

Cleared

2.8 & 3.5MM Lactoscrew Suture Anchors

K061801510(k) TraditionalCleared Aug 7, 200642-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

Arthrotek, Inc. · JDR Staple, Fixation, Bone

Cleared on Aug 7, 2006 as substantially equivalent to K041274 (Arthrotek, Inc., 2004) and 1 other predicate after a 42-day review. Its family tree reaches back 3 generations to 1995. 7 later devices descend from it.

Decided
Aug 7, 2006
Review
42 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K943806 (1995). 11 ancestors in all, the oldest K931519 (1994). 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 3 other ancestors1998: 2 other ancestors1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2008: 1 descendant cleared2011: 1 descendant cleared2020: 2 descendants cleared2013: 3 descendants clearedK943806 · Harpoon Suture Anchors · Biomet, Inc. · 1995K012872 · Resorbable Screw Anchor · Arthrotek, Inc. · 2001K041274 · Resorbable Interference Screw · Arthrotek, Inc. · 2004 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 2 descendants K041274 · Resorbable Interference Screw · Arthrotek, Inc. · 2004 · recalledK012872 · Resorbable Screw Anchor · Arthrotek, Inc. · 2001K943806 · Harpoon Suture Anchors · Biomet, Inc. · 19950
  1. Root · 3 generations backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
  2. 2 generations backK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
  3. 1 generation backK041274 Resorbable Interference ScrewArthrotek, Inc. · 2004 · Recalled
  4. This deviceK061801 2.8 & 3.5MM Lactoscrew Suture AnchorsArthrotek, Inc. · 2006
  5. Descendant · cites it directly · 6 of its ownK080088 Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · Recalled
  6. Descendant · 2 generations on · 2 of its ownK110473 Nanotack Suture Anchor 1.4MMPivot Medical · 2011
  7. Descendant · 2 generations on · 0 of its ownK193402 ALLthread PEEK Suture AnchorBiomet, Inc. · 2020
  8. Descendant · 2 generations on · 0 of its ownK192942 ALLthread Titanium Suture AnchorBiomet, Inc. · 2020
  9. Descendant · 2 generations on · 0 of its ownK123485 Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors…Biomet Sports Medicine · 2013 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2008: 12011: 12013: 32020: 2
2008high 3 (2013) · low 0 (2009)2026

Most influential descendants

Showing 5 of 7 · See all
  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · cites it directly6descendants
  • K110473Nanotack Suture Anchor 1.4MMPivot Medical · 2011 · 2 generations on2descendants
  • K193402ALLthread PEEK Suture AnchorBiomet, Inc. · 2020 · 2 generations on0descendants
  • K192942ALLthread Titanium Suture AnchorBiomet, Inc. · 2020 · 2 generations on0descendants
  • K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K943806Harpoon Suture AnchorsBiomet, Inc.1995—
−2K012872Resorbable Screw AnchorArthrotek, Inc.2001—
−1K041274Resorbable Interference ScrewArthrotek, Inc.20045
0 (this device)K0618012.8 & 3.5MM Lactoscrew Suture AnchorsArthrotek, Inc.2006—
+1K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.20088
+2K110473Nanotack Suture Anchor 1.4MMPivot Medical2011—
+2K193402ALLthread PEEK Suture AnchorBiomet, Inc.2020—
+2K192942ALLthread Titanium Suture AnchorBiomet, Inc.2020—
+2K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless…Biomet Sports Medicine20132

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199610
199820
200130

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201330
202020
FIG. 1 — Lineage of K061801, 1995–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 JDR? 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 JDR device

  1. #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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? (2)

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
*K041274Resorbable Interference Screw
Summary page 1
…ation, Biodegradable, Soft Tissue (21 CFR §888.3030) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * Resorbable Interference Screw J041274 Biomet, Inc. • LactoSorb® Screw Anchors j003273 Biomet, Inc. Device Description: The 2.8 and 3.5mm LactoScrew®…
Arthrotek, Inc.20045
*K003273Lactosorb Screw Anchor
Summary page 1
…eted Devices To Which Substantial Equivalence Is Claimed: * Resorbable Interference Screw J041274 Biomet, Inc. • LactoSorb® Screw Anchors j003273 Biomet, Inc. Device Description: The 2.8 and 3.5mm LactoScrew® Suture Anchors, which are comprised of LactoSorb® resorbable copo…
Biomet, Inc.2001—

Also cleared against K041274: 5 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.20086

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?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
  • 2 of the 11 ancestors have a recall of any class.
  • Of its descendants, K080088 (Biomet Manufacturing, Inc., 2008) has gone furthest, with 6 descendants of its own.
  • 5 other devices also cite its predicate K041274.

How does its category compare?

All JDR devices

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

FDA decisions per year · JDR

3in 2025

2007: 82008: 52010: 22011: 12012: 12013: 92014: 112015: 72016: 62017: 92018: 82019: 52020: 42021: 32022: 52023: 92024: 42025: 32026 (partial year): 2
2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007: 70 days median2008: 89 days median2013: 137 days median2014: 97 days median2015: 111 days median2016: 101 days median2017: 172 days median2018: 107 days median2019: 149 days median2020: 161 days median2021: 62 days median2022: 107 days median2023: 72 days median2024: 29 days median2025: 65 days median
2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2008: 12015: 12018: 12020: 12022: 112026 (partial year): 2
2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007: 32008: 142009: 102010: 352011: 622012: 342013: 272014: 492015: 482016: 762017: 1162018: 2392019: 2422020: 2342021: 2102022: 2022023: 1752024: 2062025: 314
2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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
200787003
2008589114
20090—010
20102—035
20111—062
20121—034
20139137027
20141197049
20157111148
20166101076
201791720116
201881071239
201951490242
202041611234
20213620210
2022510711202
20239720175
20244290206
20253650314
20262—2—

What is it indicated for?

Indications for the 2.8 and 3.5mm LactoScrew® Suture Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow and knee. Specific indications are as follows: Shoulder: Bankarl: repair, SLAP lesion repair', acromlo-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial…

Read the full statement (108 words)

Indications for the 2.8 and 3.5mm LactoScrew® Suture Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow and knee. Specific indications are as follows:

Shoulder: Bankarl: repair, SLAP lesion repair', acromlo-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair.

Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.

Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.

Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/tendon repair.

Indications for use as stated in the FDA summary.

Also cleared against K041274

5 other devices cite the same predicate.

  • K151701Tenodesis screw systemNormed Medizin-Technik GmbH · 2016
  • K103145Hammerloc TM Tibial Fixation DeviceBiomet Sports Medicine · 20112 recalls
  • K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 20071 recall
  • K071464Inion Hexalon Biodegradable Acl/PCL ScrewInion OY · 2007
  • K042552Bio-Core Interference ScrewBiomet, Inc. · 2004

More from Arthrotek, Inc.

17 FDA decisions under this applicant name. See the company

  • K061776Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc. · 2006
  • K061657Hitch Lactosorb Suture AnchorArthrotek, Inc. · 2006
  • K061389Allthread Lactosorb Suture AnchorArthrotek, Inc. · 2006
  • K060693Microstrike and Allthread Peek Suture AnchorArthrotek, Inc. · 2006
  • K053461Ezloc Femoral Fixation DeviceArthrotek, Inc. · 2006

Recent decisions in JDR

The JDR category page

  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K250712Linkt Compression Staple SystemTrax Surgical · 2025
  • K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
  • K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025

https://510kreport.com/device/K061801 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061801: 2.8 & 3.5MM Lactoscrew Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061801

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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