510(k) · Cleared
ClearedHercules Suture Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones USA, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Aug 20, 2020 as substantially equivalent to K110773 (Tornier, Inc., 2011) and 4 other predicates after a 65-day review. Its family tree reaches back 8 generations to 1992. 1 later device descends from it.
- Decided
- Aug 20, 2020
- Review
- 65 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K921873 (1992). 54 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 7 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- 6 generations backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- 5 generations backK070227 Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007
- 4 generations backK080335 Tornier Cinch Knotless Fixation Implant SystemTornier, Inc. · 2008
- 3 generations backK091870 Tornier, Piton Fixation Implant SystemTornier · 2009
- 2 generations backK110773 Tornier Insite FT Suture AnchorTornier, Inc. · 2011
- 1 generation backK150715 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc. · 2015
- This deviceK201636 Hercules Suture Anchor SystemIn2bones USA, LLC · 2020
- Descendant · cites it directly · 0 of its ownK253538 TeKBrace Knotless AnchorTheramicro · 2026
Most influential descendants
Showing 1 of 1 · See all- K253538TeKBrace Knotless AnchorTheramicro · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −7 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| −6 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| −5 | K070227 | Opus Magnum PI Knotless Fixation Device | Arthrocare Corp. | 2007 | — |
| −4 | K080335 | Tornier Cinch Knotless Fixation Implant System | Tornier, Inc. | 2008 | — |
| −3 | K091870 | Tornier, Piton Fixation Implant System | Tornier | 2009 | — |
| −2 | K110773 | Tornier Insite FT Suture Anchor | Tornier, Inc. | 2011 | — |
| −1 | K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors | Tornier, Inc. | 2015 | — |
| 0 (this device) | K201636 | Hercules Suture Anchor System | In2bones USA, LLC | 2020 | — |
| +1 | K253538 | TeKBrace Knotless Anchor | Theramicro | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K110773 | Tornier Insite FT Suture AnchorSummary page 5…ce: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA: Primary Predicate: • K110773 and K150715– Tornier Insite FT PEEK Knotless Suture Anchors Additional Predicates: • K112237 - Arthrex MicroSuture An… | 2011 |
| * | K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsSummary page 5…ect components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA: Primary Predicate: • K110773 and K150715– Tornier Insite FT PEEK Knotless Suture Anchors Additional Predicates: • K112237 - Arthrex MicroSuture Anchors… | 2015 |
| * | K112237 | Microsuture AnchorsSummary page 5…previously cleared by the FDA: Primary Predicate: • K110773 and K150715– Tornier Insite FT PEEK Knotless Suture Anchors Additional Predicates: • K112237 - Arthrex MicroSuture Anchors • K071257 and K992487 - Depuy Mitek Mini QUICKANCHOR… | 2011 |
| * | K071257 | Mini Quickanchor and Quickanchor Plus with OrthocordSummary page 5…dicate: • K110773 and K150715– Tornier Insite FT PEEK Knotless Suture Anchors Additional Predicates: • K112237 - Arthrex MicroSuture Anchors • K071257 and K992487 - Depuy Mitek Mini QUICKANCHOR Arthrex MicroSuture… | 2007 |
| * | K992487 | Mitek Mini Quickanchor PlusSummary page 5…• K110773 and K150715– Tornier Insite FT PEEK Knotless Suture Anchors Additional Predicates: • K112237 - Arthrex MicroSuture Anchors • K071257 and K992487 - Depuy Mitek Mini QUICKANCHOR Arthrex MicroSuture Depuy Mitek… | 1999 |
| † | K063778 | Force Fiber Polyethylene Nonabsorbable Suture | 2007 |
| † | K092533 | Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures | 2009 |
| † | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force… | 2018 |
| † | K182402 | CoLink View Plating System | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253538 | TeKBrace Knotless Anchor | 2026 | 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 28 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 10 of the 54 ancestors have a recall of any class.
- Of its descendants, K253538 (Theramicro, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K110773.
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. 2020, 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 In2Bones Hercules™ Suture Anchors are intended for use in the following applications: 1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction. 2. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction. 3. Knee: Medial collateral and Lateral collateral…
Read the full statement (93 words)
The In2Bones Hercules™ Suture Anchors are intended for use in the following applications:
1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
2. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
3. Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair.
4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201636 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201636: Hercules Suture Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201636
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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