510(k) · Cleared
ClearedKATOR Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kator, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 25, 2016 as substantially equivalent to K152236 (Kator, LLC, 2015) after a 61-day review. Its family tree reaches back 4 generations to 2000. 3 later devices descend from it.
- Decided
- Oct 25, 2016
- Review
- 61 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K990987 (2000). 5 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK990987 Bio-Absorbable Corkscrew, Model AR-1920BArthrex, Inc. · 2000
- 3 generations backK043337 Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc. · 2004
- 2 generations backK061665 Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc. · 2006
- 1 generation backK152236 KATOR Suture AnchorKator, LLC · 2015
- This deviceK162386 KATOR Suture AnchorKator, LLC · 2016
- Descendant · cites it directly · 2 of its ownK173269 KATOR Suture AnchorKator, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK242477 Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK182736 OIC Suture Anchor SystemThe Orthopaedic Implant Company · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990987 | Bio-Absorbable Corkscrew, Model AR-1920B | Arthrex, Inc. | 2000 | — |
| −3 | K043337 | Arthrex Bio-Corkscrew FT Suture Anchor | Arthrex, Inc. | 2004 | — |
| −2 | K061665 | Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT | Arthrex, Inc. | 2006 | — |
| −1 | K152236 | KATOR Suture Anchor | Kator, LLC | 2015 | — |
| 0 (this device) | K162386 | KATOR Suture Anchor | Kator, LLC | 2016 | — |
| +1 | K173269 | KATOR Suture Anchor | Kator, LLC | 2018 | — |
| +2 | K242477 | Shoulder Soft Tissue Anchors | Signature Orthopaedics Pty, Ltd. | 2025 | — |
| +2 | K182736 | OIC Suture Anchor System | The Orthopaedic Implant Company | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K152236 | KATOR Suture AnchorSummary page 4…aced within a bone tunnel and a suture locking pin that secures soft tissue repair sutures or suture tape within the implant. Predicate Device: The KATOR Suture Anchor (K152236) is the predicate device. KATOR LLC… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173269 | KATOR Suture Anchor | 2018 | 2 |
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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K173269 (Kator, LLC, 2018) has gone furthest, with 2 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. 2016, this device’s year, is highlighted.
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 KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.
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/K162386 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162386: KATOR Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162386
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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