510(k) · Cleared
ClearedHitch Lactosorb Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrotek, Inc. · JDR Staple, Fixation, Bone
Cleared on Jul 25, 2006 as substantially equivalent to K012572 (Biomet, Inc., 2001) after a 42-day review. Its family tree reaches back 2 generations to 1994. 8 later devices descend from it.
- Decided
- Jul 25, 2006
- Review
- 42 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931519 (1994). 5 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK931519 Acufex SuretacAcufex Microsurgical, Inc. · 1994
- 1 generation backK012572 Soft Tissue Screw and WasherBiomet, Inc. · 2001
- This deviceK061657 Hitch Lactosorb Suture AnchorArthrotek, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK080088 Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK110473 Nanotack Suture Anchor 1.4MMPivot Medical · 2011
- Descendant · 2 generations on · 0 of its ownK193402 ALLthread PEEK Suture AnchorBiomet, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK192942 ALLthread Titanium Suture AnchorBiomet, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK123485 Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors…Biomet Sports Medicine · 2013 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931519 | Acufex Suretac | Acufex Microsurgical, Inc. | 1994 | — |
| −1 | K012572 | Soft Tissue Screw and Washer | Biomet, Inc. | 2001 | — |
| 0 (this device) | K061657 | Hitch Lactosorb Suture Anchor | Arthrotek, Inc. | 2006 | — |
| +1 | K080088 | Biomet Sports Medicine Anchor Devices and Ziploop Constructs | Biomet Manufacturing, Inc. | 2008 | 8 |
| +2 | K110473 | Nanotack Suture Anchor 1.4MM | Pivot Medical | 2011 | — |
| +2 | K193402 | ALLthread PEEK Suture Anchor | Biomet, Inc. | 2020 | — |
| +2 | K192942 | ALLthread Titanium Suture Anchor | Biomet, Inc. | 2020 | — |
| +2 | K123485 | Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless… | Biomet Sports Medicine | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2020 | 2 | 0 |
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 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012572 | Soft Tissue Screw and WasherSummary page 1…astener, fixation, biodegradable,. soft tissue (21 CFR 888.3030) Legally Marketed Devices lo Which Substantial Equiralence Is Claimed: · Soft Tissue Screw and Washer (K012572) Device Description: The Hitch TM LactoSorb® Suture Anchor is made with an L-Lactide / Glycolide resorbable material, preloaded w… | 2001 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K080088 (Biomet Manufacturing, Inc., 2008) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K012572.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
Indications for the HitchTM LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, ;,nd knee. Specific indications are as follows: Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstru::tion, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstructian Elbow: Tennis elbow repair, Biceps…
Read the full statement (98 words)
Indications for the HitchTM LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, ;,nd knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstru::tion, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstructian
Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.
Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061657 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061657: Hitch Lactosorb Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061657
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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