510(k) · Cleared
ClearedInnovasive 8MM Ligament Fastener
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasive Devices, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Apr 16, 1997 after an 82-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Apr 16, 1997
- Review
- 82 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK970316 Innovasive 8MM Ligament FastenerInnovasive Devices, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK980491 Innovasive Linx Tibial Ligament FastenerInnovasive Devices, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK983056 Innovasive Tibial FastenerInnovasive Devices, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK980334 Innovasive 10MM Linx HT Ligament FastenerInnovasive Devices, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK974049 Innovasive Linx BT 10MM Ligament FastenerInnovasive Devices, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK973323 Acl Clip-inInnovasive Devices, Inc. · 1997
Most influential descendants
Showing 5 of 5 · See all- K980491Innovasive Linx Tibial Ligament FastenerInnovasive Devices, Inc. · 1998 · cites it directly1descendant
- K983056Innovasive Tibial FastenerInnovasive Devices, Inc. · 1998 · 2 generations on0descendants
- K980334Innovasive 10MM Linx HT Ligament FastenerInnovasive Devices, Inc. · 1998 · cites it directly0descendants
- K974049Innovasive Linx BT 10MM Ligament FastenerInnovasive Devices, Inc. · 1998 · cites it directly0descendants
- K973323Acl Clip-inInnovasive Devices, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970316 | Innovasive 8MM Ligament Fastener | Innovasive Devices, Inc. | 1997 | — |
| +1 | K980491 | Innovasive Linx Tibial Ligament Fastener | Innovasive Devices, Inc. | 1998 | — |
| +2 | K983056 | Innovasive Tibial Fastener | Innovasive Devices, Inc. | 1998 | — |
| +1 | K980334 | Innovasive 10MM Linx HT Ligament Fastener | Innovasive Devices, Inc. | 1998 | — |
| +1 | K974049 | Innovasive Linx BT 10MM Ligament Fastener | Innovasive Devices, Inc. | 1998 | — |
| +1 | K973323 | Acl Clip-in | Innovasive Devices, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 4 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 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 |
|---|---|---|---|
| * | — | Mitek 5 mm Ligament Anchor Named without a submission number |
What descends from it? (5)
4 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, K980491 (Innovasive Devices, Inc., 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Innovasive Devices 8mm Ligament Fastener is intended for ligament to bone reattachenent of Anterior and Posterior Cruciate Ligaments in patients with recurrent instability of the knee.
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/K970316 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970316: Innovasive 8MM Ligament Fastener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970316
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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