510(k) · Cleared
ClearedLactosorb Pop Rivet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDR Staple, Fixation, Bone
Cleared on Jul 13, 1998 after a 53-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Jul 13, 1998
- Review
- 53 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK981798 Lactosorb Pop RivetBiomet, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK143037 SnapShot Fixation SystemBiomet Manufacturing Corp · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK252635 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK262809 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
- Descendant · cites it directly · 0 of its ownK033519 Cannulated Arthrorivet and Cannulated RC ArthrorivetBiomet, Inc. · 2003
Most influential descendants
Showing 4 of 4 · See all- K143037SnapShot Fixation SystemBiomet Manufacturing Corp · 2015 · cites it directly2descendants
- K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026 · 2 generations on1descendant
- K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026 · 3 generations on0descendants
- K033519Cannulated Arthrorivet and Cannulated RC ArthrorivetBiomet, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981798 | Lactosorb Pop Rivet | Biomet, Inc. | 1998 | — |
| +1 | K143037 | SnapShot Fixation System | Biomet Manufacturing Corp | 2015 | 1 |
| +2 | K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026 | — |
| +3 | K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026 | — |
| +1 | K033519 | Cannulated Arthrorivet and Cannulated RC Arthrorivet | Biomet, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2015 | 1 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
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?
- Of its descendants, K143037 (Biomet Manufacturing Corp, 2015) has gone furthest, with 2 descendants of its own.
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?
The LactoSorb* Pop Rivets are indicated for use in soft tissue reattachment in the following procedures:
1. instability repairs in the shoulder (Bankart Procedures)
2 SLAP lesion repair
3 Acromio-clavicular separation repairs
4. Rotator cuff tear repairs,
5. Capsular shift or capsulqpral reconstructions
6 Biceps Tenodesis
7. ‘Deltéed repairs
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981798 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981798: Lactosorb Pop Rivet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981798
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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