510(k) · Cleared
ClearedMitek Fastin RC Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitek Products · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Nov 23, 1998 after a 25-day review. The FDA summary names its predicate without a number. 34 later devices descend from it.
- Decided
- Nov 23, 1998
- Review
- 25 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 2 citing it directly.
- This deviceK983818 Mitek Fastin RC AnchorMitek Products · 1998
- Descendant · cites it directly · 22 of its ownK041075 Fastin RC AnchorDepuy Mitek, A Johnson & Johnson Company · 2004 · Recalled
- Descendant · 2 generations on · 21 of its ownK082282 Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008
- Descendant · 3 generations on · 15 of its ownK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- Descendant · cites it directly · 10 of its ownK011912 Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000Axya Medical, Inc. · 2001
- Descendant · 2 generations on · 9 of its ownK052491 Axya Model 6500 Axyaloop Self-Tapping Bone AnchorAxya Medical, Inc. · 2005 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K041075Fastin RC AnchorDepuy Mitek, A Johnson & Johnson Company · 2004 · cites it directly22descendants
- K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008 · 2 generations on21descendants
- K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company · 2011 · 3 generations on15descendants
- K011912Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000Axya Medical, Inc. · 2001 · cites it directly10descendants
- K052491Axya Model 6500 Axyaloop Self-Tapping Bone AnchorAxya Medical, Inc. · 2005 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983818 | Mitek Fastin RC Anchor | Mitek Products | 1998 | — |
| +1 | K041075 | Fastin RC Anchor | Depuy Mitek, A Johnson & Johnson Company | 2004 | 1 |
| +2 | K082282 | Healix TI Anchor | Depuy Mitek, A Johnson & Johnson Co. | 2008 | — |
| +3 | K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend… | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| +1 | K011912 | Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000 | Axya Medical, Inc. | 2001 | — |
| +2 | K052491 | Axya Model 6500 Axyaloop Self-Tapping Bone Anchor | Axya Medical, Inc. | 2005 | 21 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 FASTIN® Anchor Named without a submission number |
What descends from it? (34)
See all 342 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, K041075 (Depuy Mitek, A Johnson & Johnson Company, 2004) has gone furthest, with 22 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?
Rotator cuff repair
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/K983818 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983818: Mitek Fastin RC Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983818
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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