510(k) · Cleared
Recalled · 2005Pre-Loaded Biostinger Hornet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · HWC Screw, Fixation, Bone
Cleared on May 6, 2002 as substantially equivalent to K991715 (Linvatec Corp., 1999) after a 90-day review. Its family tree reaches back 2 generations to 1998. 76 later devices descend from it. It has been recalled once.
- Decided
- May 6, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981692 (1998). 76 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK981692 Meniscal Repair DeviceLinvatec Corp. · 1998
- 1 generation backK991715 Biostinger-V Bioabsorbable Meniscal Repair DeviceLinvatec Corp. · 1999
- This deviceK020377 Pre-Loaded Biostinger HornetLinvatec Corp. · 2002
- Descendant · cites it directly · 75 of its ownK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- Descendant · 2 generations on · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- Descendant · 2 generations on · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- Descendant · 2 generations on · 25 of its ownK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- Descendant · 3 generations on · 17 of its ownK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K053561Bio-Mini Revo Suture AnchorConmed Linvatec · 2006 · cites it directly75descendants
- K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · 2 generations on56descendants
- K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011 · 2 generations on29descendants
- K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008 · 2 generations on25descendants
- K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec · 2013 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981692 | Meniscal Repair Device | Linvatec Corp. | 1998 | — |
| −1 | K991715 | Biostinger-V Bioabsorbable Meniscal Repair Device | Linvatec Corp. | 1999 | — |
| 0 (this device) | K020377 | Pre-Loaded Biostinger Hornet | Linvatec Corp. | 2002 | — |
| +1 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| +2 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| +2 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| +2 | K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | 2008 | — |
| +3 | K131035 | Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM | Linvatec Corporation D/B/A Conmed Linvatec | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K991715 | Biostinger-V Bioabsorbable Meniscal Repair DeviceSummary page 2…=== Summary of Safety and Effectiveness Pre-Loaded BioStinger Hornet™ 510()#_KodO3 77 February 4, 2002 Page 2 of 2 D. Predicate/Legally Marketed Devices BioStinger-V™ K991715 Linvatec Corporation E. Device Description The BioStinger™ Bioabsorbable Meniscal Repair Device is a cannulated, sterile, singl… | 1999 |
What descends from it? (76)
See all 761 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053561 | Bio-Mini Revo Suture Anchor | 2006 | 75 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 22, 2005 | Not classified | Z-1550-05 | Other | Linvatec has determined there is a possibility the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K053561 (Conmed Linvatec, 2006) has gone furthest, with 75 descendants of its own.
- 3 other devices also cite its predicate K991715.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The BioStinger™ Bioabsorbable Implant provides fixation of longitudinal vertical meniscus lesions (bucket handle tears) located in the vascular area of the meniscus.
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/K020377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020377: Pre-Loaded Biostinger Hornet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020377
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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