510(k) · Cleared
ClearedArthrex Suturetak Suture Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Dec 18, 2014 as substantially equivalent to K112237 (Arthrex, Inc., 2011) and 3 other predicates after a 259-day review. Its family tree reaches back 7 generations to 1996. 63 later devices descend from it.
- Decided
- Dec 18, 2014
- Review
- 259 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K961555 (1996). 11 ancestors in all. 63 later devices descend from it, 10 citing it directly.
- Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 4 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 3 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 2 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 1 generation backK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
- This deviceK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- Descendant · cites it directly · 24 of its ownK181769 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2018
- Descendant · 2 generations on · 17 of its ownK200341 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
- Descendant · 3 generations on · 16 of its ownK203268 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
- Descendant · cites it directly · 12 of its ownK151092 Arthrex Short Suture AnchorsArthrex, Inc. · 2016
- Descendant · 4 generations on · 6 of its ownK230568 FiberTak Suture AnchorArthrex, Inc. · 2023
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K181769Arthrex FiberTak Suture AnchorArthrex, Inc. · 2018 · cites it directly24descendants
- K200341Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020 · 2 generations on17descendants
- K203268Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020 · 3 generations on16descendants
- K151092Arthrex Short Suture AnchorsArthrex, Inc. · 2016 · cites it directly12descendants
- K230568FiberTak Suture AnchorArthrex, Inc. · 2023 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −6 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −5 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −4 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −3 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −2 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −1 | K110660 | Arthrex Biocomposite Suturetak | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K140855 | Arthrex Suturetak Suture Anchors | Arthrex, Inc. | 2014 | — |
| +1 | K181769 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2018 | — |
| +2 | K200341 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 | — |
| +3 | K203268 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 | — |
| +1 | K151092 | Arthrex Short Suture Anchors | Arthrex, Inc. | 2016 | — |
| +4 | K230568 | FiberTak Suture Anchor | Arthrex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 12 | 0 |
| 2024 | 4 | 0 |
| 2025 | 13 | 0 |
| 2026 | 12 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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 |
|---|---|---|---|
| * | K112237 | Microsuture AnchorsSummary page 4…ation Name, CFR 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories Predicate Device K112237: Arthrex MicroSuture Anchors K110660: Arthrex BioComposite SutureTak K0… | 2011 |
| * | K110660 | Arthrex Biocomposite SuturetakSummary page 4…llic bone fixation appliances and accessories Predicate Device K112237: Arthrex MicroSuture Anchors K110660: Arthrex BioComposite SutureTak K091844: Arthrex Bio-Composite SutureTak Suture Anchors… | 2011 |
| * | K091844 | Arthrex Bio-Composite Suturetak AnchorsSummary page 4…ories Predicate Device K112237: Arthrex MicroSuture Anchors K110660: Arthrex BioComposite SutureTak K091844: Arthrex Bio-Composite SutureTak Suture Anchors K061863: Arthrex Corkscrew, Corkscrew FT, Bio-Corksc… | 2009 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 4…K110660: Arthrex BioComposite SutureTak K091844: Arthrex Bio-Composite SutureTak Suture Anchors K061863: Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio Corkscrew FT Suture Anchors Purpose of S… | 2006 |
What descends from it? (63)
See all 6310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181769 | Arthrex FiberTak Suture Anchor | 2018 | 24 |
| K151092 | Arthrex Short Suture Anchors | 2016 | 12 |
| K223878 | Aevumed RAPID Suture Anchors | 2023 | 6 |
| K192032 | Fixone Biocomposite Small Anchor | 2020 | 4 |
| K180951 | Responsive Arthroscopy Suture Anchor System | 2019 | 4 |
| K181076 | Responsive Arthroscopy Wedge Push-In Suture Anchors | 2019 | 2 |
| K180594 | Knotless SutureTak Anchors | 2018 | 1 |
| K152255 | BoneCam Suture Anchors | 2015 | 1 |
| K231033 | CEPTRE® Knotted UHMWPE Suture PEEK Anchor | 2024 | 0 |
| K231002 | Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture… | 2023 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K181769 (Arthrex, Inc., 2018) has gone furthest, with 24 descendants of its own.
- 6 other devices also cite its predicate K112237.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Arthrex SutureTak Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament…
Read the full statement (133 words)
The Arthrex SutureTak Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular repair, Acetabular Labral repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140855: Arthrex Suturetak Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140855
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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