510(k) · Cleared
ClearedMicrosuture Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HWC Screw, Fixation, Bone
Cleared on Sep 2, 2011 as substantially equivalent to K061863 (Arthrex, Inc., 2006) and 2 other predicates after a 29-day review. Its family tree reaches back 6 generations to 1996. 77 later devices descend from it.
- Decided
- Sep 2, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K961555 (1996). 9 ancestors in all. 77 later devices descend from it, 7 citing it directly.
- Root · 6 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 3 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 2 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 1 generation backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- This deviceK112237 Microsuture AnchorsArthrex, Inc. · 2011
- Descendant · cites it directly · 63 of its ownK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- Descendant · cites it directly · 29 of its ownK140476 Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014
- Descendant · 2 generations on · 27 of its ownK151230 Arthrex FiberTak AnchorsArthrex, Inc. · 2015
- Descendant · 2 generations on · 24 of its ownK181769 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2018
- Descendant · 3 generations on · 17 of its ownK200341 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K140855Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014 · cites it directly63descendants
- K140476Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014 · cites it directly29descendants
- K151230Arthrex FiberTak AnchorsArthrex, Inc. · 2015 · 2 generations on27descendants
- K181769Arthrex FiberTak Suture AnchorArthrex, Inc. · 2018 · 2 generations on24descendants
- K200341Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −5 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −4 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −3 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −2 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −1 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| 0 (this device) | K112237 | Microsuture Anchors | Arthrex, Inc. | 2011 | — |
| +1 | K140855 | Arthrex Suturetak Suture Anchors | Arthrex, Inc. | 2014 | — |
| +1 | K140476 | Arthrex Fibertak Suture Anchor | Arthrex, Inc. | 2014 | — |
| +2 | K151230 | Arthrex FiberTak Anchors | Arthrex, Inc. | 2015 | — |
| +2 | K181769 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2018 | — |
| +3 | K200341 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 9 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 13 | 0 |
| 2024 | 5 | 0 |
| 2025 | 14 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 1…onies. 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Predicate Devices K061863: Arthrex Corkscrew Suture Anchor K0634 79: Arthrex Mini PushLock K09 1844:… | 2006 |
| * | K063479 | Arthrex PushlockSummary page 1…threaded metallic bone fixation fastener Predicate Devices K061863: Arthrex Corkscrew Suture Anchor K0634 79: Arthrex Mini PushLock K09 1844: Arthrex Micro BioComposite Suture Tak Device Description and… | 2006 |
| * | K091844 | Arthrex Bio-Composite Suturetak AnchorsSummary page 1…fastener Predicate Devices K061863: Arthrex Corkscrew Suture Anchor K0634 79: Arthrex Mini PushLock K09 1844: Arthrex Micro BioComposite Suture Tak Device Description and The Arthrex MicroSuture Anchors consist of four anchors… | 2009 |
What descends from it? (77)
See all 777 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140855 | Arthrex Suturetak Suture Anchors | 2014 | 63 |
| K140476 | Arthrex Fibertak Suture Anchor | 2014 | 29 |
| K180951 | Responsive Arthroscopy Suture Anchor System | 2019 | 4 |
| K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture… | 2015 | 4 |
| K180118 | Arthrex NanoSuture Anchor | 2018 | 2 |
| K201636 | Hercules Suture Anchor System | 2020 | 1 |
| K241695 | Extremity All Suture System | 2024 | 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 15 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K140855 (Arthrex, Inc., 2014) has gone furthest, with 63 descendants of its own.
- 33 other devices also cite its predicate K061863.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Arthrex MicroSuture Anchors 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: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction…
Read the full statement (134 words)
The Arthrex MicroSuture Anchors 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:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate 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, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
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/K112237 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112237: Microsuture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112237
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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