510(k) Report

510(k) · Cleared

Cleared

Allthread Lactosorb Suture Anchor

K061389510(k) TraditionalCleared Jul 19, 200662-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 Jul 19, 2006 as substantially equivalent to K033355 (Biomet Orthopedics, Inc., 2004) after a 62-day review. Its family tree reaches back 3 generations to 1995. 7 later devices descend from it.

Decided
Jul 19, 2006
Review
62 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
1

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

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1998: 1 other ancestor1996: 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. · 2001K033355 · Lactoscrew Screw Anchor · Biomet Orthopedics, Inc. · 20041995200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 2 descendants K033355 · Lactoscrew Screw Anchor · Biomet Orthopedics, Inc. · 2004K012872 · 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 backK033355 Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004
  4. This deviceK061389 Allthread Lactosorb Suture AnchorArthrotek, 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—
−1K033355Lactoscrew Screw AnchorBiomet Orthopedics, Inc.2004—
0 (this device)K061389Allthread Lactosorb Suture AnchorArthrotek, 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
199610
199810
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201330
202020
FIG. 1 — Lineage of K061389, 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? (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
*K033355Lactoscrew Screw Anchor
Summary page 1
…stener, fixation, biodegradable, soft tissue (21 CFR 888.3030) Legally Marketed Devices To Which Substantial Equhwalence Is Claimed: LactoScrew tM Screw Anchor (K033355) Device Description: The ALLthreadTm LactoSorb® Sutuire Anchor is made with an L-Lactidle/ Glycolide resorbable material, preload…
Biomet Orthopedics, Inc.2004—

Also cleared against K033355: 1 other device →

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 3 companies; a new generation was cleared every 2.6 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K080088 (Biomet Manufacturing, Inc., 2008) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K033355.

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 ALLthread Tm LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows: Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial…

Read the full statement (106 words)

Indications for the ALLthread Tm LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

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

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

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

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

Indications for use as stated in the FDA summary.

Also cleared against K033355

1 other device cites the same predicate.

  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 20088 recalls

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
  • 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/K061389 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061389: Allthread Lactosorb Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061389

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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