510(k) · Cleared
ClearedArthrex Knee FiberTak® Button Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Nov 15, 2023 as substantially equivalent to K231330 (Arthrex, Inc., 2023) and 1 other predicate after a 55-day review. Its family tree reaches back 14 generations to 1996. 4 later devices descend from it.
- Decided
- Nov 15, 2023
- Review
- 55 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K961555 (1996). 110 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 10 generations between
- 3 generations backK203268 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
- 2 generations backK230568 FiberTak Suture AnchorArthrex, Inc. · 2023
- 1 generation backK231330 FiberTak® Suture AnchorArthrex, Inc. · 2023
- This deviceK232973 Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK241235 Arthrex TightRope IIArthrex, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK260405 FiberTape ButtonArthrex, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250867 Dunamis Screw and Suture Locking SystemDunamis Medical, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK250424 Arthrex TightRope Soft Button, RTArthrex, Inc. · 2025
Show all 14 generations
- Root · 14 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 13 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 12 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 11 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 10 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 9 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 8 generations backK112237 Microsuture AnchorsArthrex, Inc. · 2011
- 7 generations backK140476 Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014
- 6 generations backK151230 Arthrex FiberTak AnchorsArthrex, Inc. · 2015
- 5 generations backK181769 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2018
- 4 generations backK200341 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
- 3 generations backK203268 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
- 2 generations backK230568 FiberTak Suture AnchorArthrex, Inc. · 2023
- 1 generation backK231330 FiberTak® Suture AnchorArthrex, Inc. · 2023
- This deviceK232973 Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K241235Arthrex TightRope IIArthrex, Inc. · 2024 · cites it directly3descendants
- K260405FiberTape ButtonArthrex, Inc. · 2026 · 2 generations on0descendants
- K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC · 2025 · 2 generations on0descendants
- K250424Arthrex TightRope Soft Button, RTArthrex, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −13 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −12 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −11 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −10 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −9 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −8 | K112237 | Microsuture Anchors | Arthrex, Inc. | 2011 | — |
| −7 | K140476 | Arthrex Fibertak Suture Anchor | Arthrex, Inc. | 2014 | — |
| −6 | K151230 | Arthrex FiberTak Anchors | Arthrex, Inc. | 2015 | — |
| −5 | K181769 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2018 | — |
| −4 | K200341 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 | — |
| −3 | K203268 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 | — |
| −2 | K230568 | FiberTak Suture Anchor | Arthrex, Inc. | 2023 | — |
| −1 | K231330 | FiberTak® Suture Anchor | Arthrex, Inc. | 2023 | — |
| 0 (this device) | K232973 | Arthrex Knee FiberTak® Button Suture Anchor | Arthrex, Inc. | 2023 | — |
| +1 | K241235 | Arthrex TightRope II | Arthrex, Inc. | 2024 | — |
| +2 | K260405 | FiberTape Button | Arthrex, Inc. | 2026 | — |
| +2 | K250867 | Dunamis Screw and Suture Locking System | Dunamis Medical, LLC | 2025 | — |
| +2 | K250424 | Arthrex TightRope Soft Button, RT | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 9 | 0 |
| 2000 | 7 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K231330 | FiberTak® Suture AnchorSummary page 5…MBI Classification Name 21 CFR 888.3040: Smooth or threaded metallic bone fastener Regulatory Class II Primary Predicate Device K231330: Arthrex FiberTak® Suture Anchor Additional Predicate Device K180768 Arthrex BioComposite SwiveLock® Purpose of Submission… | 2023 |
| * | K180768 | Arthrex SwiveLock AnchorsSummary page 5…or threaded metallic bone fastener Regulatory Class II Primary Predicate Device K231330: Arthrex FiberTak® Suture Anchor Additional Predicate Device K180768 Arthrex BioComposite SwiveLock® Purpose of Submission This Traditional 510(k) premarket notification is submitted to expa… | 2018 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241235 | Arthrex TightRope II | 2024 | 3 |
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 27 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 12 of the 110 ancestors have a recall of any class.
- Of its descendants, K241235 (Arthrex, Inc., 2024) has gone furthest, with 3 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. 2023, 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 Arthrex Knee FiberTak® Button Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: • Shoulder: Rotator cuff repair, Bankart repair, SLAP lesion repair, biceps tenodesis, acromio-clavicular separation repair, deltoid repair, capsular shift or capsulolabral reconstruction • Foot/Ankle: Lateral stabilization, medial stabilization, achilles tendon…
Read the full statement (148 words)
The Arthrex Knee FiberTak® Button Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
• Shoulder: Rotator cuff repair, Bankart repair, SLAP lesion repair, biceps tenodesis, acromio-clavicular separation repair, deltoid repair, capsular shift or capsulolabral reconstruction
• Foot/Ankle: Lateral stabilization, medial stabilization, achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, and digital tendon transfers
• Knee: Medial collateral ligament repair, lateral collateral ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, joint capsule closure, medial patellofemoral ligament repair/reconstruction, and quadriceps tendon repair
• Hand/Wrist: Scapholunate ligament reconstruction, carpal ligament reconstructions, repair/reconstruction of collateral ligaments digital tendon transfers, and carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Elbow: Biceps tendon reattachment, ulnar/radial collateral ligament reconstruction, and lateral epicondylitis repair
• Hip: Acetabular Labral Repair and gluteal tendon repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232973 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232973: Arthrex Knee FiberTak® Button Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232973
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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