510(k) · Cleared
ClearedKFX Knotless Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kfx Medical · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 19, 2006 as substantially equivalent to K041713 (Linvatec Corp., 2004) and 3 other predicates after a 71-day review. Its family tree reaches back 2 generations to 2001. 19 later devices descend from it.
- Decided
- Jul 19, 2006
- Review
- 71 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K003984 (2001). 6 ancestors in all, the oldest K960516 (1996). 19 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003984 Super Revo Suture AnchorLinvatec Corp. · 2001
- 1 generation backK041713 Super Revo Herculine Suture AnchorLinvatec Corp. · 2004
- This deviceK061294 KFX Knotless Fixation SystemKfx Medical · 2006
- Descendant · cites it directly · 18 of its ownK072063 KFX Tissue Fixation System and AccessoriesKfx Medical · 2007
- Descendant · 2 generations on · 16 of its ownK081598 Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue…Kfx Medical · 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 · 4 generations on · 6 of its ownK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · Recalled
- Descendant · 4 generations on · 6 of its ownK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K072063KFX Tissue Fixation System and AccessoriesKfx Medical · 2007 · cites it directly18descendants
- K081598Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce SutureKfx Medical · 2008 · 2 generations on16descendants
- K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company · 2011 · 3 generations on15descendants
- K211002Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · 4 generations on6descendants
- K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003984 | Super Revo Suture Anchor | Linvatec Corp. | 2001 | — |
| −1 | K041713 | Super Revo Herculine Suture Anchor | Linvatec Corp. | 2004 | — |
| 0 (this device) | K061294 | KFX Knotless Fixation System | Kfx Medical | 2006 | — |
| +1 | K072063 | KFX Tissue Fixation System and Accessories | Kfx Medical | 2007 | — |
| +2 | K081598 | Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200)… | Kfx Medical | 2008 | — |
| +3 | K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend… | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| +4 | K211002 | Grappler Suture Anchor System | Paragon 28, Inc. | 2021 | 1 |
| +4 | K103712 | Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K041713 | Super Revo Herculine Suture AnchorSummary page 1…ss Fixation System is substantially equivalent to existing suturing devices cleared by the Food and Drug Administration. The Linvatec Super Revo Herculine Suture Anchor (K041713), the Opus Medical Magnum Anchor with Inserter (K041440, K042914), and the Arthrex FASTak Suture Anchor (K9605 16) devices are ex… | 2004 |
| * | K041440 | Opus Magnum Anchor with InserterSummary page 1…ng suturing devices cleared by the Food and Drug Administration. The Linvatec Super Revo Herculine Suture Anchor (K041713), the Opus Medical Magnum Anchor with Inserter (K041440, K042914), and the Arthrex FASTak Suture Anchor (K9605 16) devices are examples of substantially equivalent devices with the same… | 2004 |
| * | K042914 | Opus Magnum Knotless Anchor with Inserter HandleSummary page 1…ng devices cleared by the Food and Drug Administration. The Linvatec Super Revo Herculine Suture Anchor (K041713), the Opus Medical Magnum Anchor with Inserter (K041440, K042914), and the Arthrex FASTak Suture Anchor (K9605 16) devices are examples of substantially equivalent devices with the same intended… | 2004 |
| * | K960516 | Fastak Suture AnchorSummary page 1…ration. The Linvatec Super Revo Herculine Suture Anchor (K041713), the Opus Medical Magnum Anchor with Inserter (K041440, K042914), and the Arthrex FASTak Suture Anchor (K9605 16) devices are examples of substantially equivalent devices with the same intended use, design and technology characteristics reque… | 1996 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072063 | KFX Tissue Fixation System and Accessories | 2007 | 18 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K072063 (Kfx Medical, 2007) has gone furthest, with 18 descendants of its own.
- 4 other devices also cite its predicate K041713.
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 KFx Knotless Fixation System and Accessory Targeting Grasper are intended for the
fixation of soft tissue to bone during rotator cuff repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061294: KFX Knotless Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061294
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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