510(k) · Cleared
ClearedComposite Hitch Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · JDR Staple, Fixation, Bone
Cleared on Jul 17, 2008 as substantially equivalent to K061657 (Arthrotek, Inc., 2006) and 2 other predicates after an 84-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jul 17, 2008
- Review
- 84 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K002639 (2001). 11 ancestors in all, the oldest K931519 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK002639 Bioknotless AnchorMitek Products · 2001 · Recalled
- 4 generations backK040827 Panalok Loop AnchorDepuy Mitek, A Johnson & Johnson Company · 2004 · Recalled
- 3 generations backK050771 Lupine LoopDepuy Mitek, A Johnson & Johnson Company · 2005
- 2 generations backK062170 Bioknotless and Lupine Plus AnchorsDepuy Mitek, A Johnson & Johnson Company · 2006 · Recalled
- 1 generation backK070925 Modification to: Bioknotless BR Anchor / Lupine BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2007 · Recalled
- This deviceK081172 Composite Hitch Suture AnchorBiomet Manufacturing Corp · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002639 | Bioknotless Anchor | Mitek Products | 2001 | 2 |
| −4 | K040827 | Panalok Loop Anchor | Depuy Mitek, A Johnson & Johnson Company | 2004 | 17 |
| −3 | K050771 | Lupine Loop | Depuy Mitek, A Johnson & Johnson Company | 2005 | — |
| −2 | K062170 | Bioknotless and Lupine Plus Anchors | Depuy Mitek, A Johnson & Johnson Company | 2006 | 7 |
| −1 | K070925 | Modification to: Bioknotless BR Anchor / Lupine BR Anchor | Depuy Mitek, A Johnson & Johnson Company | 2007 | 11 |
| 0 (this device) | K081172 | Composite Hitch Suture Anchor | Biomet Manufacturing Corp | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2006 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K061657 | Hitch Lactosorb Suture AnchorSummary page 1…, fixation, biodegradable, soft tissue (21 CFR 888.3030) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Hitch T"ILactoSorb® Suture Anchor, K061657, Biomet, Inc. Soft Tissue Screw and Washer, K012572, Biomet, Inc. Biocryl Rapide Bioknotless BR Anchor, K070925,… | 2006 |
| * | K012572 | Soft Tissue Screw and WasherSummary page 1…ally Marketed Devices To Which Substantial Equivalence Is Claimed: Hitch T"ILactoSorb® Suture Anchor, K061657, Biomet, Inc. Soft Tissue Screw and Washer, K012572, Biomet, Inc. Biocryl Rapide Bioknotless BR Anchor, K070925, DePuy Mitek Device Description: The Composite Hitch Suture A… | 2001 |
| * | K070925 | Modification to: Bioknotless BR Anchor / Lupine BR AnchorSummary page 1…Hitch T"ILactoSorb® Suture Anchor, K061657, Biomet, Inc. Soft Tissue Screw and Washer, K012572, Biomet, Inc. Biocryl Rapide Bioknotless BR Anchor, K070925, DePuy Mitek Device Description: The Composite Hitch Suture Anchor is made with a composite, resorbable material, The soft tissue… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K061657.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Composite HitchTM Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, 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 Elbow: Tennis elbow repair, Biceps…
Read the full statement (98 words)
Indications for the Composite HitchTM Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, 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
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/K081172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081172: Composite Hitch 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/K081172
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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