510(k) · Cleared
ClearedKsea Flipptack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Sep 22, 1998 after a 60-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Sep 22, 1998
- Review
- 60 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK982571 Ksea FlipptackKARL STORZ Endoscopy-America, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK171640 M-ARS ACL: Anatomic Ribbon Surgery SystemMedacta International S.A. · 2017
- Descendant · 2 generations on · 3 of its ownK191300 MectaLock Ti Suture AnchorMedacta International S.A. · 2019
- Descendant · 3 generations on · 2 of its ownK223582 MectaLock TI Triple Loaded Suture AnchorMedacta International S.A. · 2023
- Descendant · 4 generations on · 1 of its ownK230544 SnugFit All-Suture Anchor extensionMedacta International S.A. · 2023
- Descendant · 5 generations on · 0 of its ownK251933 SnugFit ASA ExtensionMedacta International S.A. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171640M-ARS ACL: Anatomic Ribbon Surgery SystemMedacta International S.A. · 2017 · cites it directly5descendants
- K191300MectaLock Ti Suture AnchorMedacta International S.A. · 2019 · 2 generations on3descendants
- K223582MectaLock TI Triple Loaded Suture AnchorMedacta International S.A. · 2023 · 3 generations on2descendants
- K230544SnugFit All-Suture Anchor extensionMedacta International S.A. · 2023 · 4 generations on1descendant
- K251933SnugFit ASA ExtensionMedacta International S.A. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982571 | Ksea Flipptack | KARL STORZ Endoscopy-America, Inc. | 1998 | — |
| +1 | K171640 | M-ARS ACL: Anatomic Ribbon Surgery System | Medacta International S.A. | 2017 | — |
| +2 | K191300 | MectaLock Ti Suture Anchor | Medacta International S.A. | 2019 | — |
| +3 | K223582 | MectaLock TI Triple Loaded Suture Anchor | Medacta International S.A. | 2023 | — |
| +4 | K230544 | SnugFit All-Suture Anchor extension | Medacta International S.A. | 2023 | — |
| +5 | K251933 | SnugFit ASA Extension | Medacta International S.A. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 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?
The FDA summary names no predicate by number.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171640 | M-ARS ACL: Anatomic Ribbon Surgery System | 2017 | 5 |
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, K171640 (Medacta International S.A., 2017) has gone furthest, with 5 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?
This instrument is a manually operated arthroscopic surgical device intended for suture fixation in the repair of tendons and ligaments.
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/K982571 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982571: Ksea Flipptack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982571
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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