510(k) · Cleared
ClearedFastak Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Apr 18, 1996 after a 73-day review. The FDA summary names its predicate without a number. 197 later devices descend from it.
- Decided
- Apr 18, 1996
- Review
- 73 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
197 later devices descend from it, 4 citing it directly.
- This deviceK960516 Fastak Suture AnchorArthrex, Inc. · 1996
- Descendant · cites it directly · 166 of its ownK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- Descendant · 2 generations on · 86 of its ownK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- Descendant · 3 generations on · 79 of its ownK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- Descendant · 2 generations on · 78 of its ownK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- Descendant · 2 generations on · 77 of its ownK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
Showing 5 of 197 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 197 · See all- K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998 · cites it directly166descendants
- K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998 · 2 generations on86descendants
- K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999 · 3 generations on79descendants
- K020056Duet Suture AnchorBionx Implants, Ltd. · 2002 · 2 generations on78descendants
- K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003 · 2 generations on77descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960516 | Fastak Suture Anchor | Arthrex, Inc. | 1996 | — |
| +1 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| +2 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| +3 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| +2 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| +2 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 9 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 11 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 9 | 0 |
| 2023 | 20 | 0 |
| 2024 | 17 | 0 |
| 2025 | 24 | 0 |
| 2026 | 16 | 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 GII Anchor Named without a submission number |
What descends from it? (197)
See all 1974 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, K972783 (Bionx Implants, Inc., 1998) has gone furthest, with 166 descendants 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 FASTak Suture Anchor is intended for fixation of suture to bone. This product is intended for use in repairing rotator cutf tears and Bankart lesions.
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/K960516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960516: Fastak 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/K960516
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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