510(k) · Cleared
ClearedFastak Suture Anchor (11.7MM)/(7.5MM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 30, 1997 after an 82-day review. The FDA summary names its predicate without a number. 274 later devices descend from it.
- Decided
- Jul 30, 1997
- Review
- 82 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
274 later devices descend from it, 7 citing it directly.
- This deviceK971723 Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc. · 1997
- Descendant · cites it directly · 151 of its ownK051219 PushlockArthrex, Inc. · 2005
- Descendant · cites it directly · 79 of its ownK990361 Headed Bio-Absorbable Corkscrew Model #AR-1921BUArthrex, Inc. · 1999
- Descendant · 2 generations on · 78 of its ownK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- Descendant · 2 generations on · 77 of its ownK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- Descendant · 3 generations on · 76 of its ownK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
Showing 5 of 274 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 274 · See all- K051219PushlockArthrex, Inc. · 2005 · cites it directly151descendants
- K990361Headed Bio-Absorbable Corkscrew Model #AR-1921BUArthrex, Inc. · 1999 · cites it directly79descendants
- K020056Duet Suture AnchorBionx Implants, Ltd. · 2002 · 2 generations on78descendants
- K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003 · 2 generations on77descendants
- K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd. · 2004 · 3 generations on76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971723 | Fastak Suture Anchor (11.7MM)/(7.5MM) | Arthrex, Inc. | 1997 | — |
| +1 | K051219 | Pushlock | Arthrex, Inc. | 2005 | — |
| +1 | K990361 | Headed Bio-Absorbable Corkscrew Model #AR-1921BU | Arthrex, Inc. | 1999 | — |
| +2 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| +2 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| +3 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 18 | 0 |
| 2010 | 13 | 0 |
| 2011 | 18 | 0 |
| 2012 | 12 | 0 |
| 2013 | 14 | 0 |
| 2014 | 16 | 0 |
| 2015 | 15 | 0 |
| 2016 | 4 | 0 |
| 2017 | 14 | 0 |
| 2018 | 12 | 0 |
| 2019 | 10 | 0 |
| 2020 | 15 | 0 |
| 2021 | 10 | 0 |
| 2022 | 9 | 0 |
| 2023 | 26 | 0 |
| 2024 | 14 | 0 |
| 2025 | 20 | 0 |
| 2026 | 13 | 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? (8)
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 |
|---|---|---|---|
| * | — | Mitek GII Named without a submission number | |
| * | — | Statak 3.5 Named without a submission number | |
| * | — | Questus 3.5 Named without a submission number | |
| * | — | Mainstay 3.5 Named without a submission number | |
| * | — | PeBA C Named without a submission number | |
| * | — | Statak 2.5 Named without a submission number | |
| * | — | Questus 2.5 Named without a submission number | |
| * | — | Mainstay 2.7 Named without a submission number |
What descends from it? (274)
See all 2747 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051219 | Pushlock | 2005 | 151 |
| K990361 | Headed Bio-Absorbable Corkscrew Model #AR-1921BU | 1999 | 79 |
| K050358 | Artherx Corkscrew FT II Suture Anchor | 2005 | 40 |
| K070882 | Stryker Peek Twinloop Tac | 2007 | 35 |
| K072063 | KFX Tissue Fixation System and Accessories | 2007 | 18 |
| K071520 | Renovo Suture Anchors, Models 100-2001 Thru 100-5502X | 2007 | 7 |
| K082729 | Rimclose Bone Anchor | 2008 | 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?
- Of its descendants, K051219 (Arthrex, Inc., 2005) has gone furthest, with 151 descendants of its own.
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.
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 FASTak Suture Anchor (11.7mm) is intended for fixation of suture to bone. This product is intended for the following indications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction…
Read the full statement (230 words)
The FASTak Suture Anchor (11.7mm) is intended for fixation of suture to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament chalr Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reatrachment, Tenmus Eloow Repair, Ulnar or Radial Collateral Ligamant Reconstruction
Pelvis: Bladder Neck Suspension for female urinary mcontmcnce due to urethral hyper mobility or intrinsic sphincter deficiency
The FASTak Suture Anchor (7.5mm) is intended for fixation of suture to bone. This product is intended for the following indications:
Shoulder: Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Lxgament Repair, Patellar Tendon Repair, Posterior Oblique Ligament chalr Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reatrachment, Tenmus Eloow Repair, Ulnar or Radial Collateral Ligamant Reconstruction
Peivis: Rladder Neck Suspension for female urinary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency
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/K971723 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971723: Fastak Suture Anchor (11.7MM)/(7.5MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971723
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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