510(k) · Cleared
ClearedPreloaded Soft Tissue Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Feb 20, 1996 after a 182-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 83 later devices descend from it.
- Decided
- Feb 20, 1996
- Review
- 182 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
83 later devices descend from it, 3 citing it directly.
- This deviceK953954 Preloaded Soft Tissue AnchorLinvatec Corp. · 1996
- Descendant · cites it directly · 81 of its ownK964805 Bio-AnchorLinvatec Corp. · 1997
- Descendant · cites it directly · 80 of its ownK983186 Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorLinvatec Corp. · 1998
- 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
- Descendant · 3 generations on · 76 of its ownK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K964805Bio-AnchorLinvatec Corp. · 1997 · cites it directly81descendants
- K983186Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorLinvatec Corp. · 1998 · cites it directly80descendants
- K020056Duet Suture AnchorBionx Implants, Ltd. · 2002 · 2 generations on78descendants
- K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003 · 2 generations on77descendants
- K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd. · 2004 · 3 generations on76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953954 | Preloaded Soft Tissue Anchor | Linvatec Corp. | 1996 | — |
| +1 | K964805 | Bio-Anchor | Linvatec Corp. | 1997 | — |
| +1 | K983186 | Bio-Anchor, Pre-Loaded Bioabsorbable Suture Anchor | Linvatec Corp. | 1998 | — |
| +2 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| +2 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| +3 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (83)
See all 833 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, K964805 (Linvatec Corp., 1997) has gone furthest, with 81 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 | — |
https://510kreport.com/device/K953954 · printed Nov 5, 2026
Cite this page
510(k) Report. “K953954: Preloaded Soft Tissue Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953954
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026