510(k) · Cleared
ClearedTigon Medical All-Suture Anchors (ASA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tigon Medical · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Dec 20, 2024 as substantially equivalent to K133671 (Stryker Corp., 2014) after a 116-day review. Its family tree reaches back 9 generations to 1996. 2 later devices descend from it.
- Decided
- Dec 20, 2024
- Review
- 116 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K961555 (1996). 24 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations between
- 3 generations backK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
- 2 generations backK110545 Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor…Smith & Nephew, Inc. · 2011
- 1 generation backK133671 Iconix All Suture AnchorsStryker Corp. · 2014
- This deviceK242529 Tigon Medical All-Suture Anchors (ASA)Tigon Medical · 2024
- Descendant · cites it directly · 1 of its ownK252596 Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical · 2025
- Descendant · cites it directly · 0 of its ownK260921 Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture…Tigon Medical · 2026
Show all 9 generations
- Root · 9 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 8 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 7 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 6 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 5 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 4 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- 3 generations backK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
- 2 generations backK110545 Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor…Smith & Nephew, Inc. · 2011
- 1 generation backK133671 Iconix All Suture AnchorsStryker Corp. · 2014
- This deviceK242529 Tigon Medical All-Suture Anchors (ASA)Tigon Medical · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −8 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −7 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −6 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −5 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −4 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| −3 | K101823 | Arthrex Swivelock Anchors | Arthrex, Inc. | 2011 | 6 |
| −2 | K110545 | Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK) | Smith & Nephew, Inc. | 2011 | — |
| −1 | K133671 | Iconix All Suture Anchors | Stryker Corp. | 2014 | — |
| 0 (this device) | K242529 | Tigon Medical All-Suture Anchors (ASA) | Tigon Medical | 2024 | — |
| +1 | K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical | 2025 | — |
| +1 | K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K133671 | Iconix All Suture AnchorsSummary page 5…fixation fastener Regulatory Class: II Product Code/Panel: MBI Predicate Devices: ICONIX All Suture Anchor System (K133671) Reference: Stryker Self-Punching ICONIX (K171465) Reference: Smith & Nep… | 2014 |
| † | K171465 | Stryker Self-Punching ICONIX | 2017 |
| † | K122059 | All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture… | 2013 |
| † | K230311 | HyperSuture | 2023 |
| † | K220464 | Tigon Medical Gryphon Anchor Line | 2023 |
| † | K182507 | Tigon Medical Tissue Anchors | 2019 |
What descends from it? (2)
2 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 28 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 24 ancestors have a recall of any class.
- Of its descendants, K252596 (Tigon Medical, 2025) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K133671.
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. 2024, 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 Tigon Medical All-Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications: 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 Repair Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carnal Ligament…
Read the full statement (127 words)
The Tigon Medical All-Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
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 Repair
Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carnal 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 Repair
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, lliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
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/K242529 · printed Nov 3, 2026
Cite this page
510(k) Report. “K242529: Tigon Medical All-Suture Anchors (ASA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K242529
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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