510(k) · Cleared
ClearedArthrex Bio-Composite Suturetak 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 Aug 28, 2009 as substantially equivalent to K071177 (Arthrex, Inc., 2007) after a 67-day review. Its family tree reaches back 5 generations to 1996. 100 later devices descend from it.
- Decided
- Aug 28, 2009
- Review
- 67 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K961555 (1996). 6 ancestors in all. 100 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 2 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 1 generation backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- This deviceK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- Descendant · cites it directly · 77 of its ownK112237 Microsuture AnchorsArthrex, Inc. · 2011
- Descendant · cites it directly · 64 of its ownK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
- Descendant · cites it directly · 63 of its ownK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- Descendant · cites it directly · 41 of its ownK101679 Arthrex Pushlock AnchorsArthrex, Inc. · 2010
- Descendant · 2 generations on · 29 of its ownK140476 Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014
Showing 5 of 100 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 100 · See all- K112237Microsuture AnchorsArthrex, Inc. · 2011 · cites it directly77descendants
- K110660Arthrex Biocomposite SuturetakArthrex, Inc. · 2011 · cites it directly64descendants
- K140855Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014 · cites it directly63descendants
- K101679Arthrex Pushlock AnchorsArthrex, Inc. · 2010 · cites it directly41descendants
- K140476Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014 · 2 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −4 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −3 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −2 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −1 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| 0 (this device) | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| +1 | K112237 | Microsuture Anchors | Arthrex, Inc. | 2011 | — |
| +1 | K110660 | Arthrex Biocomposite Suturetak | Arthrex, Inc. | 2011 | — |
| +1 | K140855 | Arthrex Suturetak Suture Anchors | Arthrex, Inc. | 2014 | — |
| +1 | K101679 | Arthrex Pushlock Anchors | Arthrex, Inc. | 2010 | — |
| +2 | K140476 | Arthrex Fibertak Suture Anchor | Arthrex, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 12 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 15 | 0 |
| 2024 | 6 | 0 |
| 2025 | 15 | 0 |
| 2026 | 15 | 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? (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 |
|---|---|---|---|
| * | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Summary page 1…ode - MAI - Fastener, Fixation, Biodegradable, Soft Tissue Classification Name HWIC - Screw, Fixation, Bone Predicate Device(s) Arthrex Bio-Composite Suture Anchors: K071 177 Device Description The Arthrex Bio-Composite SutureTalk Anchors family and Intended Use issimilar to the predicate devices… | 2007 |
What descends from it? (100)
See all 1004 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K112237 (Arthrex, Inc., 2011) has gone furthest, with 77 descendants of its own.
- 9 other devices also cite its predicate K071177.
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. 2009, 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 Bio-Composite Tak is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder: Specific indications are listed below and are size appropriate per patient needs: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair…
Read the full statement (135 words)
The Arthrex Bio-Composite Tak is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder: Specific indications are listed below and are size appropriate per patient needs:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
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.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091844 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091844: Arthrex Bio-Composite Suturetak Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091844
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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